Medicare Part D Open Enrollment Ends Tomorrow (December 31, 2010)

The open enrollment season for Medicare Part D runs from November 15 through December 31. During this period newly eligible beneficiaries can choose a new drug plan and existing beneficiaries can review their current prescription drug plan to ensure that it best fits their needs.
To help beneficiaries navigate through the details of different drug plans, the Centers for Medicare and Medicaid recently updated its Plan Finder tool. Visit Medicare.gov to use the Plan Finder tool.

FDA Approves Impax Doryx(R) 75 And 100MG Generic Antibiotic Tablets

Impax Laboratories Inc announced that it had received the Food and Drug Administration's approval for the company's Generic Version of the Antibiotic drug, Doryx(R) in 75 and 100mg dosages.
The drug is used for treating rickettsial infections, sexually transmitted infections, respiratory tract infections, specific bacterial infections, ophthalmic infections, anthrax, including inhalational anthrax (post-exposure), alternative treatment for selected infections when penicillin is contraindicated, adjunctive therapy in acute intestinal amebiasis and severe acne, and prophylaxis of malaria.
There is an ongoing patent infringement lawsuit filed by Warner Chilcott Limited and Mayne Pharma International Pty. Ltd.on the Impax's generic version of the drug.
Following is the Press release by Impax

Impax Laboratories Receives Final FDA Approval for Generic Doryx(R) 75 and 100mg Tablets
HAYWARD, Calif., Dec 29, 2010 (BUSINESS WIRE) -- Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application for the generic version of Doryx(R) (doxycyline hyclate delayed-release) 75 and 100mg tablets. The Company is preparing for product launch through Global Pharmaceuticals, Impax's generic division.

In December 2008, Warner Chilcott Limited and Mayne Pharma International Pty. Ltd. filed suit against the Company in the U.S. District Court for the District of New Jersey, alleging patent infringement for the filing of the Company's ANDA. Litigation is ongoing.

Doryx(R) is a tetracycline-class antibacterial indicated for rickettsial infections, sexually transmitted infections, respiratory tract infections, specific bacterial infections, ophthalmic infections, anthrax, including inhalational anthrax (post-exposure), alternative treatment for selected infections when penicillin is contraindicated, adjunctive therapy in acute intestinal amebiasis and severe acne, and prophylaxis of malaria. According to Wolters Kluwer Health, U.S. sales of Doryx(R) 75 and 100 mg were approximately $25 million in the 12 months ended October 2010.

Tiotropium Bromide Aids In Treating Uncontrolled Asthma In Adults.

Long-acting beta-agonist (LABA) therapy improves symptoms in patients whose asthma is poorly controlled by an inhaled glucocorticoid alone. Alternative treatments for adults with uncontrolled asthma are needed.

In a test involving a three-way, double-blind, triple-dummy crossover trial covering 210 patients with asthma, The team evaluated the addition of tiotropium bromide (a long-acting anticholinergic agent approved for the treatment of chronic obstructive pulmonary disease but not asthma) to an inhaled glucocorticoid, as compared with a doubling of the dose of the inhaled glucocorticoid (primary superiority comparison) or the addition of the LABA salmeterol (secondary noninferiority comparison). 

The use of tiotropium resulted in a superior primary outcome, as compared with a doubling of the dose of an inhaled glucocorticoid, as assessed by measuring the morning peak expiratory flow (PEF), with a mean difference of 25.8 liters per minute (P<0.001) and superiority in most secondary outcomes, including evening PEF, with a difference of 35.3 liters per minute (P<0.001); the proportion of asthma-control days, with a difference of 0.079 (P=0.01); the forced expiratory volume in 1 second (FEV1) before bronchodilation, with a difference of 0.10 liters (P=0.004); and daily symptom scores, with a difference of -0.11 points (P<0.001). The addition of tiotropium was also noninferior to the addition of salmeterol for all assessed outcomes and increased the prebronchodilator FEV1 more than did salmeterol, with a difference of 0.11 liters (P=0.003).

When added to an inhaled glucocorticoid, tiotropium improved symptoms and lung function in patients with inadequately controlled asthma. Its effects appeared to be equivalent to those with the addition of salmeterol. (Funded by the National Heart, Lung, and Blood Institute; ClinicalTrials.gov number, NCT00565266.).

NEJM via Pubmed

mHealth, Mobile Health Apps Gets A Search Engine From Mimvi

SAN FRANCISCO, Dec. 2, 2010 (GLOBE NEWSWIRE) -- Mimvi, Inc. (OTCBB:MIMV - News), the world's largest pure-play search, discovery and recommendation engine for finding mobile apps (or applications), has announced the launch of a specialized search and discovery engine for health-related mobile apps. The site, which is located at http://www.mimvi.com/health, provides a unique platform for companies and consumers worldwide. It is available for license to any health-related organization and other strategic partners.
Industry experts are forecasting a revolution in health-related mobile apps. A recent study by the research2guidance group predicts that the mobile healthcare market will grow exponentially to reach over 500 million mobile users, or 30 percent of an estimated 1.4 billion smartphone subscribers worldwide by 2015. Bill Gates recently validated this opportunity at the mHealth Summit, a conference for companies involved in mobile technology and health. Mr. Gates was quoted as saying, "Diagnosis of malaria and TB will likely be the first ones you can assign a number to and say without this mobile phone app these people would have died."
Kasian Franks, Mimvi's Founder and CEO, reinforced these insights, "The benefits that mobile technologies and, specifically, apps bring to healthcare are tremendous. This "megatrend" will be driven by both healthcare professionals and consumers alike. The developments we have seen to date, encompassing everything from diabetes and cholesterol management to finding the nearest ER, merely represent the tip of the iceberg. In the future, we will see all kinds of health and wellness-related applications that will save millions of lives and millions of dollars--monies which can be funneled into future research and development, as opposed to feeding a bureaucratic machine." Franks continued, "The technology that lives inside mobile devices provides so many opportunities for future innovation in the healthcare world. Think about the possibilities that cameras, environmental sensors and GPS technologies can create in saving lives and helping people proactively manage their health."
Mimvi's proprietary search and recommendation engines provide more results with greater relevance across multiple platforms than any other player in the world today--a competitive advantage that Franks went on to emphasize in the context of health, "Mimvi Health is the only specialized search and recommendation engine for healthcare in the world today. This puts us in a unique position to maximize the business opportunities for all key stakeholders: advertisers, healthcare providers and developers. This sales funnel is further widened by our proprietary Amazon-like recommendation system which provides truly meaningful suggestions--a critical component in our value proposition and the mobile apps market as a whole."
The revenue opportunities in the mobile industry are significant. A new report from BIA/Kelsey shows that U.S. mobile advertising revenues will grow from $491 million in 2009 to $2.9 billion in 2014. Mr. Franks spoke further about Mimvi's revenue model, "Our revenue strategy will include different approaches, from proven revenue models such as sponsored search results to proprietary revenue --generating technologies we are developing which will facilitate financial transactions inside the apps themselves. We will share more on this front in due course."

Schizophrenia (RG1678), Multiple Sclerosis (Ocrelizumab) Drugs By Roche Enter Phase III Of Clinical Trials.I

Roche Holding AG (ROG.VX) Thursday announced that drugs slated to treat diseases like schizophrenia, and multiple sclerosis will enter phase III of clinical trails and may submit applications for as many as 10 new drugs by the end of 2013. Roche is the world's biggest cancer drug maker and is seeking new paths outside the oncology arena to mitigate the effects of recent development setbacks. Avastin, the company’s top seller, failed in studies in prostate, stomach and early colorectal cancer.

Start of phase III programs for potential breakthrough therapies in schizophrenia and multiple sclerosis

Schizophrenia

Positive phase II proof-of-concept data with RG1678 in patients with predominantly negative symptoms of schizophrenia were recently presented at an international medical meeting³. Based on these promising results, a global phase III program has been initiated which includes a total of six studies investigating RG1678 in combination with standard of care antipsychotic drugs in patients with either negative symptoms⁴ or residual positive symptoms of schizophrenia⁵. Running the studies for both indications in parallel will allow a better understanding of the effect of RG1678 on a broad spectrum of symptoms and its value in the management of patients at different phases of their disease. The first patient was randomized into the phase III program in November 2010.

RG1678 is an investigational first-in-class glycine reuptake inhibitor that normalizes glutamate neurotransmission, thereby targeting an important pathway in the treatment of psychiatric disorders. By normalising glutamate neurotransmission in the brain, RG1678’s unique mode of action could also have valuable therapeutic applications in other psychiatric indications beyond schizophrenia.

Multiple sclerosis

Ocrelizumab, a humanized anti-CD20 antibody administered as a six-monthly infusion, demonstrated a highly significant reduction in disease activity as measured by brain lesions (96% for 2000mg and 89% for 600mg ocrelizumab dosing regimens) and relapse rate (73% for 2000mg and 80% for 600mg ocrelizumab at week 24) compared to placebo in a phase II study in relapsing-remitting multiple sclerosis (RRMS). The efficacy data, amongst the highest seen in a phase II RRMS study, were recently reported at the ECTRIMS conference. Based on these results, ocrelizumab will move into phase III studies in multiple sclerosis. Two studies will explore ocrelizumab’s efficacy in RRMS head-to-head versus interferon, the current standard of care, and one study will investigate the potential of ocrelizumab in patients with primary-progressive multiple sclerosis (PPMS).  Phase III studies for ocrelizumab will commence in the first quarter of 2011.

 Press Release by Roche

Clobazam Found To Be Positive In Adjunctive Treatment of Seizures Associated With Lennox-Gastaut Syndrome

Lundbeck A/S announced today at the 64th annual meeting of the American Epilepsy Society in San Antonio, Texas, that the study of clobazam as adjunctive therapy in treating seizures associated with Lennox-Gastaut syndrome (LGS) to be positive.Two highest dosages of clobazam as add-on therapy achieved the primary endpoint with a statistically significant reduction in average weekly rate of drop seizures, compared with placebo.. 77.6 percent of patients who received high-dosage clobazam achieved a 50 percent or greater reduction in average weekly rate of drop seizures. Lundbeck anticipates NDA submission by year-end after which the agency's confirmation of receipt of the submission will be awaited. ClinicalTrials.gov also lists this as the Phase III study of the Clobazam's effectiveness.

H. Lundbeck A/S (Lundbeck) today presented positive data from its pivotal phase III study to determine the efficacy and safety profiles of the investigational compound clobazam as adjunctive therapy in treating seizures associated with Lennox-Gastaut syndrome (LGS). In the study, clobazam met its primary efficacy endpoint and was further supported by several key secondary efficacy endpoints.1 LGS is a rare and severe form of epilepsy that is typically diagnosed in childhood and persists into adulthood.2,3 Results from this largest clinical trial to date in LGS patients were presented at the 64th annual meeting of the American Epilepsy Society in San Antonio, Texas (Poster No. 1.283).1,4
This prospective, double-blind, placebo controlled study randomized 238 patients diagnosed with LGS to one of three different dosages of clobazam or placebo. Efficacy analyses were done for the modified intent to treat population (mITT), which included all randomized patients who had baseline data, at least one dose of study drug and at least one daily seizure measurement during the maintenance period (N=217).1
Data from the study's primary endpoint showed that the high (1.0 mg/kg/day; N=49) and medium (0.5 mg/kg/day; N=58) dosages of clobazam, evaluated versus placebo (N=57), met a robust statistically significant (p≤0.01) reduction in the average weekly rate of drop seizures from the 4-week baseline period compared to the 12-week maintenance period. Patients in the high-dosage clobazam group achieved a mean decrease in average weekly rate of drop seizures of 68.3 percent (p<0.0001 vs. placebo) while those in the medium-dosage arm had an average decrease of 49.4 percent (p=0.0015 vs. placebo).1
A secondary endpoint of the study was responder rates. For each group treated with one of the three different dosages of clobazam, the percentage of patients with a decrease in average weekly rate of drop seizures of ≥25%, ≥50%, ≥75% or 100% from baseline to the maintenance period was compared to placebo. Among patients in the high-dosage arm, 77.6 percent had a 50 percent or greater reduction (p<0.01); 63.3 percent had a 75 percent or greater reduction (p<0.01); and 24.5 percent achieved 100 percent reduction. Among patients in the medium-dosage arm, 58.6 percent had a 50 percent or greater reduction (p<0.05); 37.9 percent had a 75 percent or greater reduction (p<0.01); and 12.1 percent achieved 100 percent reduction. The logistic regression model used in this study was unable to provide valid p-value estimates for the 100 percent response thresholds due to the small number of patients enrolled in this group.1

"LGS is a devastating form of epilepsy associated with multiple types of seizures, including dangerous drop seizures which may cause falls that often result in injury. This can take a tremendous toll on even the strongest families," said Joan A. Conry, MD, professor of neurology at Children's National Medical Center in Washington, D.C., and a principal investigator in the study. "While several medications are approved in the U.S. for treatment of LGS, many patients continue to have seizures due to the intractable nature of the disease. The focus on this small patient population and the results of this study provide hope for LGS patients, their families and the medical community."

The study also evaluated the effect of clobazam in decreasing total seizures (drop and non-drop) as another key secondary endpoint. Robust statistical significance was observed in patients who received the high- and medium-dosage clobazam (p<0.01 in each arm versus placebo).1
In the study, the most common treatment emergent adverse events (AEs) included somnolence, lethargy, drooling, fever, and constipation. Serious AEs occurring in ≥2 patients were lobar pneumonia and pneumonia, which occurred in both clobazam and placebo treatment arms.1
"Lundbeck makes several treatment options available in the U.S. for people affected by epilepsy, and the development of clobazam for those with LGS represents our ongoing commitment to making a difference in the lives of those affected by rare and challenging seizure disorders," said Timothy M. Cunniff, PharmD, vice president of global regulatory affairs at Lundbeck. "We are encouraged by these phase III results and look forward to submitting an NDA very soon for clobazam."

About the Study
This phase III trial was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to assess the efficacy and safety of clobazam as adjunctive therapy in patients with LGS. Patient age ranged from 2-54, with a mean age at baseline of 12.4 years. Patients were included if they were being treated with one to three antiepileptic drugs (AEDs) at stable dosages for ≥30 days before screening and had ≥2 drop seizures per week during the 4-week baseline period.1
Prior to randomization, patients were stratified by weight (12.5 kg to ≤30 kg, >30 kg) and then randomized to placebo (N=59) or one of three dosages of clobazam: low (N=58 at 0.25 mg/kg/day up to a maximum of 10 mg per day), medium (N=62 at 0.5 mg/kg/day; maximum daily dosage of 20 mg per day), and high (N=59 at 1.0 mg/kg/day; maximum daily dosage of 40 mg). Of 238 patients randomized, a total of 217 comprised the modified intent to treat (mITT) population, which included all randomized patients who had baseline data, ≥1 dose of study drug, and ≥1 daily seizure measurement during the maintenance period. A total of 177 patients completed the study. Statistical significance for the primary efficacy endpoint was prespecified as p≤0.01 and considered robust statistical evidence in a single multi-center study, and p≤0.05 for secondary measures.1

About Clobazam
Clobazam is a 1,5-benzodiazepine that potentiates the inhibitory action of gamma-aminobutyric acid (GABA) by binding to GABA-A receptors.5,6 Additionally, research has identified three subtypes of the benzodiazepine omega receptor (ω).5 Diffusely distributed throughout the CNS, these ω receptors demonstrate a variety of pharmacological effects.6 In non-clinical studies, clobazam was shown to have higher affinity for the ω2 compared to the ω1 receptor.5 The precise mechanism of action by which clobazam exerts its antiepileptic effects is unknown.
The current study is part of a clinical development program to obtain FDA approval for clobazam as adjunctive treatment for patients with LGS. Clobazam is marketed outside of the U.S. in more than 100 countries under various brand names, including Frisium® or Urbanyl®. Brand names listed are property of their owners

Press release

Merck Is Ending The Isentress Phase III study, As The Drug Fails Once-a-day Treatment

 Based on the initial results of the study, which failed disappointingly, Merck the the U.S. based drugmaker announced that it was ending the Phase III study, which could have paved the way for wider use among previously untreated HIV or AIDS patients. Isentress is a leading drug for Merck and it is also one of the  fastest-growing drugs treating HIV-1 patients  . Its sales in the third quarter was $278 million, putting it on track to become a $1 billion-a-year drug for the company. Some analysts have predicted the drug to bring in 2 Billion annually by 2015.
Merck stocks took a bit of dive after the announcement. 
Following is the press release by Merck
WHITEHOUSE STATION, N.J., Nov. 29, 2010 - Merck today reported initial results from the Phase III study investigating the efficacy and safety of a treatment regimen including ISENTRESS^® (raltegravir) Tablets once daily in treatment-naïve adult patients infected with HIV-1. ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve and treatment-experienced adults. In the study, although the treatment regimen that included ISENTRESS once daily enabled more than 80 percent of patients to achieve viral suppression, ISENTRESS once daily did not demonstrate non-inferiority to the treatment regimen that included ISENTRESS twice daily. Merck said that based on the initial results and following the recommendation of an independent Data Monitoring Committee, Merck will end the study. Merck is notifying clinical investigators of this decision this week and is recommending that patients enrolled in the once-daily dosing arm of the study be switched to ISENTRESS twice daily, the FDA-approved dose. Results from this study will be submitted for presentation at an appropriate scientific meeting in 2011.
This Phase III study evaluated the safety and efficacy of an investigational once-daily dose of raltegravir (800 mg once daily) versus the approved twice-daily dose (400 mg twice daily), each given in combination with a once-daily fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, in adult treatment-naïve HIV-1-infected patients. In this study, 775 patients were randomized, and 770 patients received study drug and are included in the current analyses. After 48 weeks in the study, 83.2 percent (n=318/382) of patients receiving the regimen including ISENTRESS once daily achieved undetectable viral levels (HIV-RNA <50 copies/mL), compared to 88.9 percent (n=343/386) of patients receiving the regimen including ISENTRESS twice daily. The treatment difference between the 800 mg once daily group and 400 mg twice daily group was -5.7 percent, with an associated 95 percent confidence interval (CI) of (-10.7 percent, -0.83 percent). The difference did not meet the pre-defined statistical criteria for non-inferiority.
The overall treatment difference observed between the once-daily and twice-daily groups was primarily due to results in patients with high viral load. Among patients with more than 100,000 copies/mL of HIV-RNA, 74.3 percent (n=113/152) of those in the once-daily group achieved viral suppression compared to 84.2 percent (n=128/152) of those in the twice-daily group. The safety and tolerability profiles of the two regimens were similar in the study, and were consistent with current labeling for ISENTRESS.
About ISENTRESS
ISENTRESS is Merck's integrase inhibitor for the treatment of HIV-1 infection in treatment-naïve and treatment-experienced adult patients. ISENTRESS currently is the only approved integrase inhibitor for the treatment of HIV-1. The label for ISENTRESS is based on analyses of plasma HIV-1 RNA levels through 96 weeks in three double-blind controlled clinical studies of ISENTRESS. Two of these studies were conducted in clinically advanced, three-class antiretroviral (ARV) [non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitor (PI)] treatment-experienced adults and one was conducted in treatment-naïve adults. The safety and efficacy of ISENTRESS have not been established in pediatric patients. The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response.
ISENTRESS is the first medicine to be approved in a class of antiretroviral drugs called integrase inhibitors. ISENTRESS works by inhibiting the insertion of HIV-1 DNA into human DNA by the integrase enzyme and has demonstrated rapid antiviral activity. Inhibiting integrase from performing this essential function limits the ability of the virus to replicate and infect new cells. Other HIV-1 drugs in use inhibit two other enzymes critical to the HIV-1 replication process – protease and reverse transcriptase – but ISENTRESS is the only approved drug that inhibits the integrase enzyme. ISENTRESS is now approved in more than 90 countries worldwide. Merck is continuing to move forward with filings in additional countries around the world for use of ISENTRESS in both treatment-experienced and treatment-naïve HIV-infected patients.
Important safety information about ISENTRESS
ISENTRESS does not cure HIV or AIDS and does not prevent passing HIV to others. Healthcare providers should know that immune reconstitution syndrome has been reported in patients treated with ARV therapy, which may necessitate further evaluation and treatment.
Creatine kinase elevations were observed in subjects who received ISENTRESS. Myopathy and rhabdomyolysis have been reported. ISENTRESS should be used with caution in patients at increased risk of myopathy or rhabdomyolysis, such as patients receiving concomitant medication known to cause these conditions.
The most commonly reported drug-related adverse event (AE) of moderate to severe intensity that occurred in greater than or equal to 2 percent of patients and at a higher incidence than efavirenz in treatment-naïve patients receiving ISENTRESS was insomnia (4 percent versus 3 percent, respectively).
The most commonly reported (greater than or equal to 2 percent in either treatment group) drug-related clinical AE of moderate or severe intensity in treatment-experienced patients receiving ISENTRESS and at a higher rate compared to placebo was headache (2 percent vs. less than 1 percent) for ISENTRESS plus optimized background therapy (OBT) and placebo plus OBT, respectively.
In treatment-experienced patients, rash occurred more often in patients taking ISENTRESS and darunavir together than with either drug separately. Rashes were mild to moderate in severity and did not limit therapy. There were no discontinuations due to rash.
Dosing and administration
ISENTRESS is a single 400 mg tablet taken twice daily without regard to food. The dose of ISENTRESS should be increased during coadministration with rifampin to 800 mg twice daily.
Drug interactions
Co administration with strong inducers of uridine diphosphate glucuronosyltransferase (UGT) 1A1 may reduce plasma concentrations of ISENTRESS. Rifampin, a strong inducer of (UGT) 1A1 reduces plasma concentrations of ISENTRESS. Based on the results of drug interaction studies and the clinical trials data, no dose adjustment of ISENTRESS is required when co administered with other ARV agents. Also, preclinical studies show that ISENTRESS is not metabolized by cytochrome P450 enzymes.
For more information, visit www.merck.com.

Dietary Reference Intakes for Calcium and Vitamin D, A New Report

The report “Dietary Reference Intakes for Calcium and Vitamin D” will be released to the public on November 30, 2010 at 10 am Eastern. The report release will be broadcast via live video webcast. 
If you like to watch the webcast, you need to register and that could be done by following this link, 'Register for this Meeting' The webcast will also be made available for viewing online about a week after the release.
At the time of the release, it will be possible to view the report online at www.iom.edu/vitamind or by linking to the website of the National Academies Press (www.nap.edu).  The report will also be available for purchase as hardcopy or as a PDF from the National Academies Press.
The last recommended level for those two nutrients was made in 1997 and since then various studies have found many benefits of Vitamin D and also have linked the deficiency of it to higher risk of cancer, cardiovascular disease, depression, infectious disease and other ailments.
With the push from various quarters like supplement makers, it is possible that the Institute of Medicine will raise the “dietary reference intake’’ for vitamin D. The current recommendations are 200 international units for people 50 and younger; 400 I.U. for those aged 51 to 70; and 600 I.U. for those 71 and above.
Then why is Calcium there? It is because one of the main roles of vitamin D is to help maintain the right levels of calcium in our bodies, therefor both of them are often considered together.
Institute of Medicine via NYT

Xanodyne Pharmaceuticals, Inc. Pulls Darvon® and Darvocet-N® Products

Xanodyne Pharmaceuticals Inc., the manufacturer of Darvon and Darvocet-N, widely used painkillers in the U.S. taking the products off the market because of a new study linking the active ingredient in the drugs to serious and sometimes fatal heart rhythm abnormalities.
The drug maker initiated the ban at the request of the Food and Drug Administration, which also asked makers of generic versions of the drugs' core compound, propoxyphene, to stop selling it in the U.S.
Following is the press release;

NEWPORT, Kentucky -- Xanodyne Pharmaceuticals, Inc. announced today that the company will voluntarily withdraw its Darvon®, Darvon-N®, and Darvocet-N® products from the U.S. market in consultation with the U.S. Food and Drug Administration (FDA).
This withdrawal is part of a market-wide withdrawal applying to all propoxyphene-containing products, affecting branded and generic pharmaceutical companies and a number of products on the market. 
Propoxyphene is a mild opiate used for the treatment of mild-to-moderate pain and has been on the U.S. market for the last 50 years.
On January 30, 2009, a meeting of the FDA Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee was convened to review the efficacy and safety of propoxyphene-containing products.  Following that meeting, Xanodyne agreed to work together with the FDA, and took a number of steps including developing a patient medication guide, strengthening several of the warnings in the product labeling, and conducting a clinical study to assess the maximum tolerated dose and effects of propoxyphene on cardiac conduction.
As a result of the availability and ongoing analysis of drug safety surveillance data and developing clinical information about the effects of propoxyphene on cardiac conduction, the FDA has determined that the benefits of propoxyphene-containing products no longer outweigh the potential risks.  Patients should consult their physicians for instructions on how to safely transition to appropriate alternatives.  For further information, patients can call Xanodyne’s medical information line in the United States at 1 (877) 773 7793 or visit www.xanodyne.com.
Contact:

Josh Galper
Orrick, Herrington & Sutcliffe LLP
202 339 8468
Jgalper@orrick.com

Cardinal Health to buy NY pharma distributor Kinray for $1.3 Billion

DUBLIN, Ohio, Nov. 18, 2010 /PRNewswire-FirstCall/ -- Cardinal Health (NYSE: CAH) today announced plans to acquire Kinray, Inc., a leading pharmaceutical distributor serving the New York metropolitan area, for $1.3 billion in an all-cash transaction that will significantly expand its ability to serve retail independent pharmacies in the northeastern United States.
Cardinal Health expects the transaction to be neutral to slightly accretive to non-GAAP earnings in fiscal 2011, depending on the timing of the closing. The company estimates accretion in fiscal 2012 of at least $0.12 in non-GAAP earnings per share from continuing operations(1), including the impact of amortization of intangibles. This estimate is dependent on the timing of the closing and final valuation of intangibles.
"Adding Kinray to the Cardinal Health Pharmaceutical Segment portfolio will enable us to build on our increasing presence in community pharmacy and accelerate our growth in this important channel," said George Barrett, chairman and chief executive officer of Cardinal Health. "We are excited to have the Kinray employees join the Cardinal Health family, and we look forward to their contributions. Kinray has a long-standing service tradition with its customers. We intend to continue that tradition, utilizing its customer expertise and Whitestone distribution facility, while creating additional value for its customers through branded pharmaceutical programs, inventory and pharmacy management tools and Cardinal Health's extensive generic drug program."
With annual sales in excess of $3.5 billion, Kinray currently serves more than 2,000 retail independent pharmacy customers as a distributor of both branded and generic pharmaceuticals. The company primarily serves the New York metropolitan area and will establish a stronger platform for Cardinal Health in the northeastern U.S. The addition of Kinray will continue to diversify and broaden Cardinal Health's customer mix by increasing the company's retail independent pharmacy base by 40 percent to approximately 7,000 total customers. Subject to customary closing conditions and regulatory approvals, Cardinal Health plans to complete the transaction by the end of the calendar year or early in 2011.
"Joining forces with Cardinal Health supports Kinray's mission to help retail independent pharmacies serve as an integral provider of care for our evolving health care system," said Stewart Rahr, president and chief executive officer of Kinray. "The combination of Kinray's distribution model with the benefits of the value-added services offered by Cardinal Health will benefit our customers, making them even more efficient and successful in caring for their patients. It also provides our people with the opportunity to join one of the world's premier health care companies – one that understands the value we bring to the retail independent pharmacies we serve."
After the transaction is complete, Kinray customers will be able to tap into a leading line of service offerings from Cardinal Health including its SOURCE(SM) Generics program and additional tools that help improve the back office efficiency of retail pharmacies, including inventory management tools, reimbursement services, managed care contracting services, Specialized Care Centers and local store marketing programs.
Cardinal Health

Medicare Open Enrollment Open Now.

Medicare Open Enrollment opens up in every fall, this fall is no difference. Follow the link to see a video and resource links for help with Medicare Open Enrollment, which will be open from November 15 to December 31.

Oncowikia Blog: Medicare Open Enrollment Open From November 15 To December 31 2010

National Diabetes Month, November! Do Something To Stop, Prevent Diabetes.

November is the American Diabetes Month, even though everyone should be aware of the decease that affects many a people all over the world. It is preventable, or could be delayed with right amount of work. The Diabetes.org is carrying out a campaign to make people aware of diabetes and ways and means to prevent it.
In series of articles and bloggings and may other activities, we too can let as many people know about this decease.
Here is an interview by Dayle with celebrity Bret Michaels,who also suffer from type 1 diabetes;

You’ve had a very busy and extremely successful year so far – what inspired you to add representing American Diabetes Month as the Face of Diabetes to everything else?
This cause is so important to me. Being diagnosed with type 1 diabetes at such a young age had a profound impact on me – it’s a huge part of who I am, so of course this is something I feel incredibly passionate about.

Diabetes doesn’t have to derail your dreams.  I’m so proud to be the “Face of Diabetes;” if my work can remind other people who are struggling with the disease that it is possible to manage diabetes and still live an amazing life, then I’m happy.
What’s your daily diabetes routine look like?
Every day is a battle. You have to wake up and say to yourself, ‘I accept that I have diabetes, and I’m not going to let it run my entire life.’ It’s a fine line, a catch-22, a balancing act. I work to enjoy my life like a regular human being and at the same time keep my blood sugar levels as decent as possible.

Do you find it harder to maintain when you’re on tour?

For sure, being on the road for months on end can mess with my routine. I test my blood sugar about six to eight times a day and eat smaller meals all day long to keep my blood sugar even.
Did you ever struggle with how diabetes fits into your identity?  If so, how did you overcome this?

This is disease is something I’ve been struggling with for more than four decades.  Diabetes is undeniably a huge part of who I am and it is definitely something I’ve worked hard to come to grips with. At the same time, I’ve never let it limit me or hold me back. All I can do is take it one day at a time and be thankful for every day I handle successfully.
You were diagnosed at a young age – what do you remember?
I was six years old when I was diagnosed with diabetes; I remember I was in between kindergarten and first grade. It came on really quickly and I will never forget how extremely sick and dehydrated I was. Everything I drank or ate immediately came out of me. At  two or three in the morning my mom and dad took me to the Harrisburg hospital (in Harrisburg, PA) – the doctors in the emergency room knew what the problem was right off the bat; they recognized that it was type 1 diabetes immediately.
What do you wish someone had told you when you were first diagnosed? What would you say to kids who have just been diagnosed?
When I was first diagnosed I had no idea what was happening to me or going on inside my body. Before my parents took me to the hospital, my stomach was bloated and I was literally drinking almost a gallon of water at a time. Because my parents didn’t know what diabetes was, they were giving me soda to drink, which was not only dehydrating me more, but making my blood sugar go up twice as much. Learning more about the disease and how to keep your blood sugar stable is hugely important in living with the disease, so I would tell kids who have been diagnosed to definitely accumulate as much knowledge as possible about diabetes, just be aware and arm yourself with as much information as you can.
We just celebrated Halloween a few weeks ago, which can be tricky for kids with diabetes.  What was that like for you as a kid?  And, because we’re curious – what did you dress up as? (I’m secretly hoping David Cassidy is an answer here…)
I love Halloween now with my daughters, and I loved it as a kid, too. Even without all the candy. Just dressing up and having a good time going out with all of my friends – for me that was what the holiday was all about.  And you know, I never dressed up as David Cassidy as a kid but maybe I should borrow your idea for next year, it might make a good costume…
Thanks so much for taking the time to share a little about you with us. We hope you have a very happy American Diabetes Month! Do you have any special activities planned for November to celebrate/acknowledge this?
This being American Diabetes Month, I’m trying to speak out about the disease as much as possible.  I really want to be a positive role model for others in the diabetes community who are suffering, so I’m going to stick to my daily routine, keep my blood sugar stable, serve as a positive role model, and take every opportunity to spread awareness about the disease.
Sounds like a great plan! If you could tell the world one thing about diabetes, what would it be?
Diabetes is a disease, yes, but it’s manageable one. You can have diabetes and still accomplish all kinds of unbelievable things. If I can help remind people of that, then I’m incredibly honored. If anything, diabetes is just a challenge to overcome – a prompt to be mindful of and grateful for my health, and a cue to dream bigger and do more.
Diabetes.org

Terbinafine and Amitriptyline - Dry mouth, dizziness, and cardiac toxicity caused by prolonged increase in amitriptyline and nortriptyline (Pamelor) levels

Terbinafine and Amitriptyline

Affecting Drug 

D01BA02  Terbinafine

Effect

Augments

Affected Drug

N06AA09  Amitriptyline

Details

Dry mouth, dizziness, and cardiac toxicity caused by prolonged increase in amitriptyline and nortriptyline (Pamelor) levels

Evidence

Good

Cytochrome P450 enzymes are essential for the metabolism of many medications. Although this class has more than 50 enzymes, six of them metabolize 90 percent of drugs, with the two most significant enzymes being CYP3A4 and CYP2D6. Genetic variability (polymorphism) in these enzymes may influence a patient's response to commonly prescribed drug classes, including beta blockers and antidepressants. Cytochrome P450 enzymes can be inhibited or induced by drugs, resulting in clinically significant drug-drug interactions that can cause unanticipated adverse reactions or therapeutic failures. Interactions with warfarin, antidepressants, antiepileptic drugs, and statins often involve the cytochrome P450 enzymes. Knowledge of the most important drugs metabolized by cytochrome P450 enzymes, as well as the most potent inhibiting and inducing drugs, can help minimize the possibility of adverse drug reactions and interactions. Although genotype tests can determine if a patient has a specific enzyme polymorphism, it has not been determined if routine use of these tests will improve outcomes. 

Reference

http://www.aafp.org/afp/2007/0801/p391.html

oncowikia : Researchers Find A signaling pathway that, when blocked, significantly decreases the spread of pediatric bone cancer.

oncowikia Blog: Pathway That Drives Spread of Pediatric Bone Cance...: "Researchers have identified an important signaling pathway that, when blocked, significantly decreases the spread of pediatric bone cancer...."

FDA Approves Avanir's NUDEXTA, For Treating PSEUDOBULBAR AFFECT

*NUEDEXTA IS FIRST AND ONLY FDA-APPROVED TREATMENT FOR PSEUDOBULBAR AFFECT*

*AVANIR TO HOST CONFERENCE CALL ON NOVEMBER 1, 2010 AT 8:15 AM EASTERN TIME*

ALISO VIEJO, Calif., Oct. 29 /PRNewswire-FirstCall/ -- AVANIR Pharmaceuticals, Inc. (Nasdaq: AVNR) today announced that the U.S. Food and Drug Administration (FDA) has approved NUEDEXTA™ (dextromethorphan hydrobromide and quinidine sulfate) capsules, as the first treatment for pseudobulbar affect.

NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA). PBA occurs secondary to a variety of otherwise unrelated neurological conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the patient's underlying emotional state.
"The FDA approval of NUEDEXTA marks an important milestone for people living with PBA, an under-recognized and debilitating neurologic condition," said Keith Katkin, president and chief executive officer of Avanir. "The approval of NUEDEXTA also marks AVANIR's transition toward becoming a commercial enterprise, ready to support the successful launch of the first FDA-approved treatment for PBA. We expect that NUEDEXTA will be available by prescription during the first quarter of 2011."
"This FDA approval represents a significant step forward for people who live with the debilitating effects of PBA," said Dr. Nicholas LaRocca, Vice President of Healthcare Delivery and Policy Research at the National MS Society. "For people who experience unexplained bouts of inappropriate laughing or crying, this new therapy has the potential to substantially help both them and their families."
"Today's approval of NUEDEXTA is a testament to the conviction of the patients and researchers who participated in our studies and represents over 10 years of research and development by our dedicated employees," said Randall Kaye, MD, Chief Medical Officer, AVANIR Pharmaceuticals. "We are very pleased to bring the first proven treatment option to the many patients in the U.S. living with PBA. I would like to thank FDA for working closely with us to make NUEDEXTA available."
"PBA is a disabling neurologic condition commonly found in patients with underlying neurologic diseases or injuries. These patients frequently experience embarrassment due to their unpredictable emotional outbursts, leading to disruption of their interpersonal relationships and social isolation," said Erik P. Pioro, MD, PhD, FRCPC, Director of the Section for ALS and Related Disorders at the Cleveland Clinic in Cleveland, Ohio and an investigator in clinical studies evaluating NUEDEXTA. "As a physician who has cared for many patients with PBA, I am pleased that there is now a safe and effective treatment option for PBA that may help these patients regain more control over their daily lives and live with dignity."
NUEDEXTA is a first-in-class medication that acts on sigma-1 and NMDA receptors in the brain, although the exact mechanism by which NUEDEXTA exerts therapeutic effects in patients with PBA is unknown. Studies to support the effectiveness of NUEDEXTA were performed in patients with amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). NUEDEXTA has not been shown to be safe and effective in other types of emotional lability that can commonly occur, for example, in Alzheimer's disease and other dementias.
The primary outcome measure, laughing and crying episodes, was significantly lower in the NUEDEXTA arm compared to placebo. The secondary outcome measure, the Center for Neurologic Studies Lability Scale (CNS-LS), demonstrated a significantly greater mean decrease in CNS-LS score from baseline for the NUEDEXTA arm compared to placebo.
Conference Call
AVANIR will hold a conference call and audio webcast on November 1, 2010 at 8:15 a.m. Eastern time. To participate in the conference call, please dial 877-558-3407 (domestic) or 706-679-1941 (international) and reference the access code 22130601. A live audio webcast of the conference call will be available by visiting AVANIR's website at www.avanir.com. To listen to the live presentation, please go to AVANIR's website prior to the start of the presentation to register, download and install the necessary software. An archive of the conference call will be available on the Company's website for 30 days.

Hi-Tech Life Styles Like Games, Texting Are Affecting Childrens Sleep, Health, Study Finds.

With the new hi-tech toys available in every home and every bedroom, children are playing games, watch TV, Texting and emailing long after bedtime according to a new study. These children develop dyslexic learning problems the following morning due to lack of sleep..
The study covered 40 students sent, on average, 33.5 texts or emails per school night after bedtime -- from 10 minutes to four hours after ''lights out,"  says researcher  Peter G. Polos, MD, attending  physician at the JFK Medical Center sleep laboratory in Edison, N.J.
He is due to present his findings this week at CHEST 2010, the annual meeting of the American College of Chest Physicians in Vancouver, British Columbia.
''It reaffirms my suspicion that the availability of these media to children can or will have a significant impact on their quality and quantity of sleep, Most of the 40 students reported either learning, behavioral, or cognitive issues. This [emailing and texting] is more stimulatory than television, I think," Polos told WebMD.

Dr. Polos and his colleagues surveyed the students, ages 8 to 22, with an average age of 14.5, who had come to the sleep clinic on their sleep habits. More than 77% of the students had persistent problems getting to sleep, he says. The team found boys are more likely to surf the Internet and play games online after bedtime, while girls are more likely to use their cell phone or send text messages.
The 33.5 emails and texts were sent to about four people during a school night.
The average number of awakenings per night due to media was one.
The average number  of  texts sent per month including weekend nights after bedtime was 3,404 per person.
The older the student, the more time he or she was likely to spend texting and emailing after bedtime.
Polos found. “That number reflects a portion of children who were excessively using the media.”
 
The pilot study, Polos says, suggests that bedtime media use "may have an adverse impact on sleep hygiene and daytime function which may be significant." The study didn't prove cause and effect between late-night texting and emailing and impairments in daytime functioning, Polos says. But, he says, a student with a learning disability, for instance, who is also sleepy probably won't be performing at school at his best.
So make kids bedrooms a electronic free zone and make the healthy.

Make the bedroom a technology-free zone, with no TVs, cellphones, iPods, computers or video games

Turn off electronic devices at least half an hour before bed

LATUDA® (lurasidone HCL) for the Treatment of Patients with Schizophrenia Approved By FDA.

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) has approved LATUDA^® (lurasidone HCl) tablets for the treatment of schizophrenia. LATUDA is an oral, once-daily atypical antipsychotic, offering a first-line treatment option for patients with schizophrenia and is expected to be available in the U.S. during the first quarter of 2011.
“LATUDA marks both a significant achievement for our company as well as the first FDA approval for Sunovion since becoming the U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd.,” said Masayo Tada, president and chief executive officer, Dainippon Sumitomo Pharma Co., Ltd. “With this approval, we’ve taken another big step towards becoming a truly competitive global company by enhancing the presence of Sunovion in the United States.”
Schizophrenia is a chronic, disabling and serious brain disorder that affects approximately 2.4 million American adults or 1 in 100 people. Schizophrenia is characterized by symptoms such as hallucinations, delusions, disorganized thinking, lack of emotion, lack of energy, as well as problems with memory, attention and the ability to plan, organize and make decisions.
“LATUDA offers a once-daily treatment option that has been shown to be both effective and tolerable, adding to psychiatrists’ ability to address the challenging therapeutic needs of people with schizophrenia,” said Antony Loebel, M.D., executive vice president, Clinical Research and Medical Affairs at Sunovion Pharmaceuticals Inc.
The FDA reviewed data from more than 40 clinical trials involving approximately 2,700 LATUDA-treated adult subjects. The efficacy of LATUDA for the treatment of schizophrenia was established in four pivotal, 6-week placebo-controlled clinical trials. In these studies, LATUDA demonstrated significantly greater improvement versus placebo on the primary efficacy measures [the Positive and Negative Syndrome Scale (PANSS) total score and the Brief Psychiatric Rating Scale-derived from PANSS (BPRSd)] at study endpoint. A total of five clinical trials contributed to the understanding of the tolerability and safety profile of LATUDA.
“Schizophrenia is associated with severe and debilitating symptoms such as delusions, hallucinations and disorganized thinking, and it can often have a devastating impact on patients and their families,” said Herbert Meltzer, M.D., professor of psychiatry and pharmacology, Vanderbilt University School of Medicine. “Based on the results of the clinical trials, LATUDA represents an important addition to the treatment of schizophrenia.”

Diet Pill Qnexa Rejected By FDA Citing Health Risks

Food and Drug Administration, FDA have decided not to approve an experimental diet drug, Qnexa. Vivus Inc., the manufacturer of the drug, announced in a press statement that the FDA declined to approve the drug in its present form. The agency asked for more study results and additional information on its possible health risks, including suicidal thoughts, heart palpitations, memory lapses and birth defects.

With obesity affecting many people across the globe, pressure to find a drug is high and this is the second drug to be rejected by FDA within a week. Last week FDA rejected drug lorcaserin, by Arena Pharmaceuticals.

MOUNTAIN VIEW, Calif., Oct 28, 2010 /PRNewswire via COMTEX News Network/ -- VIVUS, Inc. (Nasdaq: VVUS) announced today that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for the investigational new drug QNEXA(R) (phentermine/topiramate) Controlled-Release Capsules. The FDA issued the CRL to communicate its decision that the NDA cannot be approved in its present form. The application seeks the approval to market QNEXA as an oral, once-a-day formulation for the treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with co-morbidities such as hypertension, type 2 diabetes, dyslipidemia or central adiposity.

The CRL included the following areas: clinical, labeling, REMS, safety update, and drug scheduling.

In the clinical section of the CRL, the FDA requested a comprehensive assessment of topiramate's and phentermine/topiramate's teratogenic potential. This will include a detailed plan and strategy to evaluate and mitigate the potential teratogenic risks in women of childbearing potential taking the drug for the treatment of obesity. In addition, the FDA asked VIVUS to provide evidence that the elevation in heart rate associated with phentermine/topiramate does not increase the risk for major adverse cardiovascular events.

The FDA requested that VIVUS formally submit the results from the already completed SEQUEL study (OB-305), a 52-week extension study for a subset of 675 patients who completed the previously reported 56-week CONQUER study. Top-line results from the two-year SEQUEL study were announced by VIVUS on September 21, 2010 and a final study report is being prepared for submission to the NDA.

The FDA reserved the right to comment further on proposed labeling. On REMS, the FDA requested that a discussion of an already submitted REMS plan be continued after the written response from VIVUS has been submitted. The agency also requested a safety update of any new adverse events be submitted to the NDA. Finally, the FDA stated that if approved, phentermine/topiramate would be a Schedule IV drug due to the phentermine component.

As part of the written response, VIVUS plans to compile analyses integrating existing nonclinical and clinical data to provide a comprehensive assessment of the teratogenic potential of topiramate. In addition, VIVUS plans to provide several new analyses to demonstrate QNEXA does not increase the risk for major cardiovascular events, which would include data from our OB-305 and OB-204 studies. In the CRL, no new clinical studies were requested; however, in the event that any of the FDA concerns are not alleviated, additional clinical studies may be required.

"We remain confident in the efficacy and safety profile of QNEXA demonstrated in the clinical development program and look forward to continue working with the FDA towards the approval for the treatment of obesity," said Leland Wilson, chief executive officer of VIVUS. "We are preparing a comprehensive response to the CRL for submission to the FDA in approximately six weeks."

Medicare Explained!

Do you know about Medicare and what does it cost? Do you know what medicare cover? Medicare has two parts Medicare Part A and Medicare Part B.
Medicare Part A:  Hospital Insurance and helps to pay for hospital, hospice and home health care.
Medicare Part B:  Medical Insurance and and helps pay for doctors, outpatient care, and other medical services.
Both are very important and depending on ones age, social security status and of course timely application for Medicare.
One retirement planner asked  Charles Schwab's  Ask Carrie the following question;

I'm turning 65 next year. I’m still working and plan to continue for at least a couple more years, so I won't yet file for Social Security. I do, however, want to get Medicare. What do I need to do to make sure I get the right coverage?

I think the answers were great and everyone should read. Take care with Medicare.
Ask Carrie

oncowikia on Cancer And You,Wordpress, Keywords...

oncowikia Blog: Cancer And You, Source For Cancer Related Keywords...: "Iwas checking on ONCOWIKIA on search engines, I found that Cancer and You site listed just below my post on Meddesktop, ONCOWIKIA and ONCOSE..."

ONCOWIKIA and ONCOSEMANTIC, Will Be Caring For Cancer.

cancer (KAN-ser) or malignancy is a term for diseases in which abnormal cells divide without control and can invade nearby tissues. Cancer cells can also spread to other parts of the body through the blood and lymph systems. There are several main types of cancer.
Carcinoma is a cancer that begins in the skin or in tissues that line or cover internal organs.
Sarcoma is a cancer that begins in bone, cartilage, fat, muscle, blood vessels, or other connective or supportive tissue.
Leukemia is a cancer that starts in blood-forming tissue such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the blood.
Lymphoma and multiple myeloma are cancers that begin in the cells of the immune system.
Central nervous system cancers are cancers that begin in the tissues of the brain and spinal cord.

The ONCOWIKIA will cover every and each information, possible about cancer or malignancy with the help of health care professionals. We will also cover the treatment, treatment process and related medicines and regiments will all be a part. These information will also be provided through ONCOSEMANTIC as a social media hub related to cancer information and avenues to fend it.
Some of the cancer types are;

    * Bladder cancer
    * Bone cancer
    * Breast cancer
    * CNS/Brain cancer
    * Colon and Rectum cancer
    * Endocrine cancer
    * Esophagus cancer
    * GYN (Non-Ovary) cancer
    * GYN (Ovary) cancer
    * Head and Neck cancer
    * HIV-Related Cancers
    * Hodgkin's Lymphoma cancer
    * Kidney (Renal Cell) cancer
    * Leukemia cancer
    * Liver and Bile Duct cancer
    * Lung cancer
    * Multiple Myeloma cancer
    * Myelodysplastic Syndrome cancer
    * Myeloproliferative Diseases cancer
    * Non-Hodgkin's Lymphoma cancer
    * Pancreas cancer
    * Pediatric Cancers
    * Prostate cancer
    * Rare Cancers
    * Skin (Melanoma) cancer
    * Skin (Non-Melanoma) cancer
    * Soft-Tissue Sarcoma cancer
    * Stomach cancer
    * Testicle cancer
and many more specific cancer information will be disseminated via ONCOWIKIA and ONCOSEMANTIC sites..  
For now you will find ONCOWIKIA Blog providing information and the progress of the development of the sites.

IZDIO.COM The SOurce Of ICD-10 Coding Informtion.

IZDIO.COM released following information on their first and foremost activity, Providing ICD-10_PCS information to patients, Healthcare workers, Doctors ,Nurses or anyone seeking ICD-10 data and information;

THE INTERNATIONAL CLASSIFICATION OF DISEASES Tenth Revision Procedure Coding System (ICD-10-PCS) was created to accompany the World Health Organization’s (WHO) ICD-10 diagnosis classification. The new procedure coding system was developed to replace ICD-9-CM procedure codes for reporting inpatient procedures.
Unlike the ICD-9-CM classification, ICD-10-PCS was designed to enable each code to have a standard structure and be very descriptive, and yet flexible enough to accommodate future needs. Information about the structure, organization, and application of ICD-10-PCS codes, along with reference material for coding with ICD-10-PCS, is provided in this manual.
IZDIO, and IZDIO.COM will work on the following parts ofICD-10-PCS:
◆What is ICD-10-PCS?
◆ICD-10-PCS code structure
◆ICD-10-PCS system organization
◆ICD-10-PCS design
◆ICD-10-PCS additional characteristics
◆ICD-10-PCS applications
In addition, we will present more specific information on coding with ICD-10-PCS as the site forms.

Abbott Laboratories agrees to withdraw its obesity drug Meridia (sibutramine)

Meridia (sibutramine): Market Withdrawal Due to Risk of Serious Cardiovascular Events
[Posted 10/08/2010] Abbott Laboratories agrees to withdraw its obesity drug Meridia
FDA Earlier Alerted Public about the fact;
"Meridia (sibutramine) increases their risk of heart attack and stroke in patients with a history of cardiovascular disease"

“Meridia’s continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke,” said John Jenkins, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research (CDER). “Physicians are advised to stop prescribing Meridia to their patients and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs.”

AUDIENCE: Primary Care, Consumers
ISSUE: Abbott Laboratories and FDA notified healthcare professionals and patients about the voluntary withdrawal of Meridia (sibutramine), an obesity drug, from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke.
BACKGROUND: Meridia was approved November 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease. The approval was based on clinical data showing that more people receiving sibutramine lost at least 5 percent of their body weight than people on placebo who relied on diet and exercise alone. FDA has now requested market withdrawal after reviewing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). SCOUT is part of a postmarket requirement to look at cardiovascular safety of sibutramine after the European approval of the drug. The trial demonstrated a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and death, in a group of patients given sibutramine compared with another given placebo. There was a small difference in weight loss between the placebo group and the group that received sibutramine.
RECOMMENDATION: Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs.

[10/08/2010 - Drug Safety Communication - FDA]
[10/08/2010 - Questions and Answers - FDA][10/08/2010 - News Release - FDA]
Previous MedWatch Alert:
[01/21/2010 - Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review]

Potentially harmful stimulant sibutramine found in Beautiful Health Inc's Slimming Beauty Bitter Orange Slimming Capsules.

[Posted 10/08/2010] Potentially harmful stimulant found in Slimming Beauty capsules
AUDIENCE: Consumers
ISSUE: FDA notified consumers that Slimming Beauty Bitter Orange Slimming Capsules contain the active pharmaceutical ingredient sibutramine, a prescription-only drug which is a stimulant. Sibutramine is not listed on the product label and could harm consumers, especially those with cardiovascular conditions, because it can lead to elevated blood pressure, stroke, and heart attack. Consumers who are otherwise healthy and who take the amount of sibutramine found in Slimming Beauty capsules can experience anxiety, nausea, heart palpitations, a racing heart, insomnia, and elevated blood pressure. Sibutramine also may interact with other medications and can cause serious side effects.
BACKGROUND: Slimming Beauty is being sold over the Internet by Beautiful Health Inc., formerly LL Health and Beauty. Slimming Beauty sample packets also have been distributed by individuals at community events.
RECOMMENDATION: Consumers should discontinue use immediately. The FDA News Release provides product photos.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

HealthCare Droid From Panasonic Washes Hair Of Patients.

Panasonic robot development engineer Tohru Nakamura displays a prototype model of hair-washing machine that makes 3D scanning of the user's head, shampoos and massages with 16 'fingers' at the annual Home care and Rehabilitation exhibition in Tokyo. -- PHOTO: AFP

'With 16 fingers, the robot washes hair and rinses the shampoo bubbles with the dexterity of human fingers,' the company said in a statement.
Panasonic unveiled on Thursday a robot who scans a client's head using 3D technology, then shampoos their hair and massages the scalp with 16 rubbery 'fingers'. The machine was developed to help the Japanese healthcare facilities now are filling with aging populace and diminishing healthcare personnel. The robot was at the annual Homecare and Rehabilitation exhibition in Tokyo.
HCR 2010

Rogue Online Phamacies Taken To Court By Google.

Google advertising is as wide as Google search and there will always be rogues playing for their place. Some times we wonder how come these spammy ads appear on our sites, specially from Google, endangering lives with unauthorized pharmaceuticals sales, which can be dangerous without the right prescription.
Google is telling us that it has been fighting these rogues with extensive verification procedures, automated keyword blocking, to changing our ads policies but still those bad people managed to sneak in.
So Google has;

" filed a civil lawsuit in federal court against advertisers we believe have deliberately broken our rules. Litigation of this kind should act as a serious deterrent to anyone thinking about circumventing our policies to advertise illegally on Google. As we identify additional bad actors, we will add them to the lawsuit. Rogue pharmacies are bad for our users, for legitimate online pharmacies and for the entire e-commerce industry—so we are going to keep investing time and money to stop these kinds of harmful practices."

Good one Google, How about those spammers with similar informatio asking us to visit those sites. You can find them in any GMail Spam folder! :)

Official Google Blog: Taking rogue pharmacies to court

FDA Extends The Review Of Avastin For Breast Cancer By Another 3 Months.

Avastin, a cancer fighting drug is under examination and FDA has announced today that the review will be extended by another 90 days. The review is to decide if the drug should be used in treatment of breast Cancer. The expensive drug seem to have not worked very well on breast cancer patients.
Avastin was approved by FDA in 2008 for breast cancer patients based on a trial. As a condition of approval, Roche, parent company of Genentech was required to conduct follow-up studies to demonstrate further the benefits of adding Avastin to conventional chemotherapy.In July an FDA advisory committee recommended the FDA, to revoke the Avastin's approval for breast cancer.

If the FDA revokes the approval, it's believed insurance companies will stop paying for this drug, which could cost more than $8,000 a month. Only the very rich will be able to afford the treatment.

Wellness, Fitness Features Enhances Google Health

Google Health launched about two years ago, provide users to have their health record in one accessible place. Health Records on Google Health are protected and only available to approved entities to view digest and help the user, like personal physician or a doctor in distant land while you are holidaying.
The new features on Google Health focuses on Wellness and fitness by adding new features and collaborating with industry leaders in providing additional services to Google Health users.
The Google Health team has developed an easier-to-use dashboard that brings together even more of users health and wellness information in one place, making it easier to organize and act on that information.
Users are now able to collect the data they need to track wellness, fitness goals and their progress with,
Fitbit, maker of a wearable device that captures health and wellness data such as steps taken, calories burned and sleep quality
CardioTrainer, one of the top mobile apps for tracking fitness activity and weight loss.

The new design also brings user ability to take notes and keep a journal of their progress through health conditions or medications response.
Google has also added more healthcare data providers, like Lucile Packard Children’s Hospital at Stanford, University of Pittsburgh Medical Center (UPMC) and Sharp HealthCare.
Official Google Blog: A Google Health update

an

Stand Up To Cancer

There is no telling how much we help someone or ourselves, by standing up to cancer. I am working in the field, everyday, in the computing, moving vast data about cancer treatments leaves me in wonderment. I get frustrated everyday seeing how hospitals drug companies, treat people like money making machines.
But I am now watching "Stand Up To Cancer" and gives me the strength to stand up, to cancer and all the evil. Just one gesture can change a lot!

su2c

Join Stand Up To Cancer You can donate with facebook credit.

Huber Needles From Multi-Med, Inc., & Navilyst Medical Inc., Recalled

AUDIENCE: Risk Manager, Surgery, Critical Care Medicine
ISSUE: FDA notified healthcare professionals of the Class I Recall of certain Huber needles that were determined by FDA testing to produce cores when inserted into ports. Coring may lead to infection, damage or death of tissue, swelling, or other serious adverse health consequences, occurring as a result of the core travelling through blood vessels into the patient’s lungs. These issues may potentially cause death.
BACKGROUND: Following hospital reports to the FDA of leakage after accessing the port with a Huber needle (labeled to be non-coring), FDA conducted its own laboratory testing of Huber needles from multiple manufacturers. Huber needles are safety needles used on vascular access ports implanted in patients in need of repeated intravenous therapy. A "coring" Huber needle could damage the implanted port by removing silicone slivers from the access membrane. The defect in the port as a result of coring can cause the ports to leak. The core can also potentially enter a patient’s body when the port is initially accessed if it is not flushed correctly.
RECOMMENDATION: Clinicians should immediately discontinue use of the recalled products. If you must use the kit, consider using an alternative, unaffected non-coring needle if possible.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[08/26/2010 - Recall Notice - FDA] See Below;
Previous MedWatch Alert:
[01/26/2010 - Recall Notice - FDA]

Huber needles are safety needles used on vascular access ports implanted in patients in need of repeated intravenous therapy. A "coring" Huber needle could damage the implanted port by removing silicone slivers from the access membrane. The defect in the port as a result of coring can cause the ports to leak. The core can also potentially enter a patient’s body when the port is initially accessed if it is not flushed correctly. These issues may lead to the decreased effectiveness of the port, replacement of the port, infection, damage or death of tissue, swelling, or other serious adverse health consequences occurring as a result of the core travelling through blood vessels into the patient’s lungs. These issues may potentially cause death.
Recall Class: Class I
Date Recall Initiated: May 26, 2010
Products:
Multi-Med, Inc.

• 22 Gauge x 1 inch straight Huber needles
  Model 10600218, Lot 9B020M.
• 22 Gauge Right Angle x 1 inch Huber needles
  Model 10600219, Lot 9B017M

These products were not sold individually; they were sold to Navilyst and packaged in certain lots of Vaxcel Implantable Vascular Access Systems. The Navilyst vascular access systems containing these defective needles can be identified in the list below.
Navilyst Medical, Inc.*

• Certain lots of Vaxcel Implantable Vascular Access Systems with PASV (Pressure Activated Safety Valve) Technology
• Certain lots of Vaxcel Implantable Vascular Access Systems

* Navilyst Medical Inc. bought Boston Scientific Oncology Division in 2008; therefore, some recalled Vaxcel Implantable Vascular Access Systems are labeled as Boston Scientific products.
To find the complete list of products affected by this recall, see list below (Navilyst Medical, Inc. and Boston Scientific Vaxcel Implantable Vascular Access Systems Containing Huber Needles: Products Affected by the Class I Huber Needle Recall).
The affected devices were manufactured from May 2, 2007 to May 1, 2010 and were distributed from May 2, 2007 to May 1, 2010.
Use:
Huber needles are used to access ports implanted under the skin of patients. These needles are intended to penetrate the port septum without cutting or dislodging any silicone cores (or slivers) from the ports into which they are inserted.
Recalling Firms:
Multi-Med, Inc.
26 Victoria Ct.
Keene NH 03431
Navilyst Medical, Inc.
10 Glens Falls Technical Park
Glens Falls, New York 12801
Reason for Recall:
In September and November 2009, FDA sampled and tested Navilyst Medical, Inc. products containing Huber-style needles manufactured by Multi-Med, Inc. FDA testing determined that these needles “cored” in 23 to 86 percent of tests.
Public Contact:Navilyst Medical Inc. may be contacted by phone at 1-800-833-9973, Monday through Friday, during the hours of 8:00 AM and 7:00 PM (Eastern Standard Time); and by FAX at 1-518-742-4450.
Multi-Med Inc. representative Susan Starkey can be contacted by phone at 1-603-357-8733, Monday through Friday, from 8:00 to 5:00 PM (Eastern Standard Time) for instructions for disposition of the needles.
FDA Districts: New York (Navilyst Medical, Inc.) and New England (Multi-Med, Inc.)
FDA Comments:The company has advised:
Distributors:

• Immediately examine your inventory and quarantine product subject to therecall.
• Identify customers that have received these needles and notify them at once of this product recall.

Clinicians/Users:

• Immediately discontinue use of the product.
• If you must use the kit, consider using an alternative, unaffected non-coring needle if possible. However if you do not have an alternate and unaffected non-coring needle, consider performing the following flushing procedures of the port as recommended by the FDA:
  • Avoid flushing the syringe when initially confirming needle patency upon accessing the port. If the needle has cored the port, flushing may introduce the core into the patient’s body, and could lead to serious adverse events.
  • When possible, upon accessing the port, consider aspirating a small amount of blood from the port after septum puncture, then discard the syringe with its contents. This step may recapture the silicone sliver. If the needle becomes clogged when attempting to aspirate, remove the needle, discard it and select a new one.
  • Watch for signs and/or symptoms that may indicate damage to the port’s septum, such as medication leakage resulting in inadequate therapy delivery, along with tissue, nerve and/or muscle damage; and redness of the surrounding area.
  • Patients should continue to follow their doctor’s recommendations for receiving treatment.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by FAX.
Useful Links:

• Information About Huber Needles
• MedWatch: The FDA Safety Information and Adverse Event Reporting Program

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List of Affected Products: Navilyst Medical, Inc. Vaxcel Implantable Vascular Access Systems Containing Huber Needles: Products Affected by the Class I Huber Needle Recall. This list also includes those products labeled under Boston Scientific.
NAVILYST MEDICAL INC. PRODUCTS

Product	Catalog Number	UPN Number	Lot Number
Vaxcel Port with PASV Titanium Mini-Port with PASV Valve and 6F Polyurethane Catheter (1.1 mm/1.9 mm)	45-213	M001452130	1192327 1252584 1303564 1194228 1258101 1307354 1198103 1259057 1307625 1199717 1263710 1308513 1200699 1266809 1313095 1203533 1267689 1316267 1214352 1271309 1343197 1214648 1273698 1346939 1215656 1276597 1354063 1219022 1280329 1360019 1225627 1285143 1364758 1228411 1286832 1365528 1232462 1290363 1369511 1235617 1292668 1373470 1239039 1294048 1377611 1240898 1295863 4001730 1244262 1297670 4006506 1246155 1299166 4014211 1251020 1300520
Vaxcel Port with PASV Titanium Mini-Port With PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm)	45-215	M001452150	1193952 1242309 1316807 1194229 1244263 1319163 1194579 1245541 1323431 1198421 1247037 1325747 1199718 1248431 1330396 1202167 1253940 1333308 1203534 1257022 1336009 1208682 1258102 1340118 1209895 1259516 1343198 1210594 1263711 1346938 1214353 1264323 1347894 1214354 1265770 1351419 1214649 1267690 1354064 1215000 1268134 1355339 1216849 1272662 1359540 1218388 1274410 1361868 1219023 1276420 1364432 1219914 1278339 1366291 1220172 1281570 1368296 1220871 1282582 1369512 1225940 1285144 1371077 1226999 1287097 1372172 1228412 1288648 1372901 1229800 1292158 1373965 1230457 1294049 1374540 1230716 1295864 1375756 1232463 1298107 1377315 1233532 1300117 4000285 1235319 1304146 4001731 1236547 1307355 4003056 1239040 1309261 4006508 1239320 1310503 4007735 1240035 1313467 4014212 4014213
Vaxcel Port with PASV Titanium Mini-Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm)	45-220	M001452200	1193953 1248432 1311034 1195311 1250527 1313096 1198104 1252585 1313097 1200700 1257023 1348374 1202457 1258103 1353274 1204614 1263712 1355601 1207340 1265771 1356197 1207664 1267691 1365529 1214355 1273901 1367037 1214650 1277633 1368843 1215657 1281030 1370103 1216850 1285145 1372521 1221191 1288649 1374541 1227000 1294048 1377316 1228413 1294480 1377612 1231143 1295865 1377844 1232464 1296141 1378093 1235320 1296709 1378345 1239041 1297923 1380085 1239321 1300521 1381887 1240899 1307356 4000284 1244264 1307357 4001732 1247038 1307358 4007724 4014661
Vaxcel Port Titanium Mini-Port with 6F Polyurethane Catheter (1.1 mm/1.9 mm)	45-303	M001453030	1267692 1320987 1283242 1327651 1284566 1344772 1290025 1359287 1296410 1366292 1300524 1370777 1306963 1377613 1312590 4001733
Vaxcel Port Titanium Mini-Port with 7F Polyurethane Catheter (1.3 mm/2.2 mm)	45-305	M001453050	1263713 1302380 1267693 1309262 1283243 1310743 1287605 1319164 1292865 1323675 1299860 1357022 1372173
Vaxcel Port Titanium Mini-Port with 8F Silicone Catheter (1.5 mm/2.6 mm)	45-310	M001453100	1263714 1286080 1321707 1264775 1287098 1345647 1267694 1288650 1346950 1269714 1292669 1354323 1272320 1294481 1355340 1273699 1295072 1359541 1275502 1297671 1360401 1276598 1299594 1364170 1283244 1301292 1367275 1284100 1310032 1373685 1285146 1312322 1381270 1285400 1316808 4001734
Vaxcel Port Titanium Standard Port with 9F Polyurethane Catheter (1.8 mm/2.8 mm)	45-315	M001453150	1264324 1294761 1277462 1304148 1288305 1320497 1356811
Vaxcel Port Titanium Standard Port with 8F Silicone Catheter (1.5 mm/2.6 mm)	45-320	M001453200	1264960 1283246 1342235 1371638
Vaxcel Port Plastic Standard Port with 8F Silicone Catheter (1.5 mm/2.6 mm)	45-340	M001453400	1263715 1277463 1294482 1332871
Vaxcel Port Plastic Standard Port with 9F Polyurethane Catheter (1.8 mm/2.8 mm)	45-360	M001453600	1267697 1290638 1317254 1342462 1362918
Vaxel Port with PASV Titanium Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm)	45-362	M001453620	1192332 1252586 1341521 1198106 1257028 1349623 1202172 1258107 1351954 1204956 1262111 1357024 1206895 1265536 1359288 1208684 1267698 1362390 1214359 1268135 1363949 1214651 1275216 1365530 1219666 1278343 1371855 1227904 1286359 1373199 1230056 1288651 1374542 1231144 1292866 1377845 1233993 1295866 1379701 1239665 1305978 4001736 1243253 1308308 4007727 1245545 1314993 4010947 1248436 1321214 1282267D 1251234 1329618
Vaxcel Port with PASV Titanium Standard Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm)	45-364	M001453640	1193957 1243254 1296998 1198107 1250135 1299862 1198423 1252587 1307903 1199454 1257029 1311285 1200701 1258424 1316268 1206362 1266810 1334583 1214360 1267699 1351212 1224333 1277308 1354065 1228418 1278344 1355341 1229803 1285147 1365531 1239044 1285594 1367038 1240037 1289476 1370574 4007741
Vaxcel Port w PASV Plastic Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm)	45-366	M001453660	1193958 1250136 1327177 1198108 1257030 1332149 1204957 1260760 1336928 1214361 1263716 1341264 1216851 1267700 1344773 1223413 1271896 1347895 1225631 1278345 1353759 1227631 1278799 1356587 1228419 1281754 1359289 1229804 1285148 1362391 1231145 1290364 1363950 1232870 1294050 1366735 1233994 1297426 1372174 1235321 1305979 1373686 1239045 1307359 1376248 1239666 1308767 1380992 1243255 1311690 4001737 1247040 1318214 4010940 4014270
Vaxcel Port with PASV Plastic Standard Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm)	45-368	M001453680	1192334 1244265 1285401 1192739 1248437 1290026 1198109 1252588 1290639 1201031 1257031 1292159 1214652 1258108 1294051 1216852 1261021 1294762 1219667 1265537 1295867 1229805 1265995 1296142 1232871 1267701 1302934 1235618 1270135 1305980 1239046 1275503 1307360 1239323 1276599 1334584 1244265 1277634 1364172 1239046 1281571 4000283 1239323 1285149

BOSTON SCIENTIFIC PRODUCTS

Product	Catalog Number	UPN Number	Lot Number
Vaxcel Port with PASV Titanium Mini-Port with PASV Valve and 6F Polyurethane Catheter (1.1 mm/1.9 mm)	45-213	M001452130	1192327 1232462 1267689 1194228 1235617 1271309 1198103 1239039 1273698 1199717 1240898 1276597 1200699 1244262 1280329 1203533 1246155 1285143 1214352 1251020 1286832 1214648 1252584 1290363 1215656 1258101 1292668 1219022 1259057 1294048 1225627 1263710 1295863 1228411 1266809 1297670
Vaxcel Port with PASV Titanium Mini-Port With PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm)	45-215	M001452150	1193952 1219914 1244263 1194229 1220172 1245541 1194579 1220871 1247037 1198421 1225940 1248431 1199718 1226999 1253940 1202167 1228412 1257022 1203534 1229800 1259516 1208682 1230457 1263711 1209895 1230716 1264323 1210594 1232463 1265770 1214353 1233532 1267690 1214354 1235319 1268134 1214649 1236547 1288648 1215000 1239040 1292158 1216849 1239320 1295864 1218388 1240035 1300117 1219023 1242309
Vaxcel Port with PASV Titanium Mini-Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm)	45-220	M001452200	1193953 1227000 1258103 1195311 1228413 1265771 1198104 1231143 1267691 1200700 1232464 1273901 1202457 1235320 1277633 1204614 1239041 1281030 1207340 1239321 1285145 1207664 1240899 1288649 1214355 1244264 1294480 1214650 1247038 1295865 1215657 1248432 1296141 1216850 1250527 1296709 1221191 1252585 1297923
Vaxcel Port Titanium Mini-Port with 6F Polyurethane Catheter (1.1 mm/1.9 mm)	45-303	M001453030	1284566
Vaxcel Port Titanium Mini-Port with 8F Silicone Catheter (1.5 mm/2.6 mm)	45-310	M001453100	1273699 1285400 1286080 1287098
Vaxcel Port Titanium Standard Port with 9F Polyurethane Catheter (1.8 mm/2.8 mm)	45-315	M001453150	1294761
Vaxel Port with PASV Titanium Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm)	45-362	M001453620	1192332 1227904 1252586 1198106 1230056 1267698 1202172 1231144 1268135 1204956 1233993 1278343 1206895 1239665 1286359 1208684 1243253 1295866 1214359 1245545 1305978 1214651 1248436 1282267D 1219666 1251234
Vaxcel Port with PASV Titanium Standard Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm)	45-364	M001453640	1193957 1243254 1267699 1198107 1250135 1277308 1198423 1252587 1285147 1199454 1257029 1296998 1200701 1258424
Vaxcel Port w PASV Plastic Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm)	45-366	M001453660	1193958 1231145 1260760 1198108 1232870 1263716 1204957 1233994 1267700 1214361 1235321 1278345 1216851 1239045 1278799 1223413 1239666 1281754 1225631 1243255 1285148 1227631 1247040 1290364 1228419 1250136 1294050 1229804 1257030 1297426
Vaxcel Port with PASV Plastic Standard Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm)	45-368	M001453680	1192334 1244265 1281571 1192739 1239046 1285149 1198109 1239323 1285401 1201031 1244265 1290026 1214652 1248437 1290639 1216852 1252588 1292159 1219667 1261021 1294051 1229805 1265537 1294762 1232871 1267701 1295867 1235618 1270135 1296142 1239046 1276599 1302934 1239323 1277634 1305980

Addresses

Navilyst Medical Legal Manufacturer Navilyst Medical, Inc. 26 Forest Street Marlborough, MA 01752 USA USA customer Service 800 833-9973 Made in the USA 10 Glens Falls Technical Park Glens Falls, NY 12801 USA

Boston Scientific Medi-Tech® Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 USA USA Customer Service 888 272-1001