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Friday, October 29, 2010

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."

Tuesday, October 26, 2010

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

Tuesday, October 12, 2010

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..."

Monday, October 11, 2010

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.

Friday, October 08, 2010

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


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