Victrelis (boceprevir) Approved By FDA To Treat Chronic Hepatitis C

FDA approves Victrelis for Hepatitis C

The U.S. Food and Drug Administration today approved Victrelis (boceprevir) to treat certain adults with chronic hepatitis C. Victrelis is used for patients who still have some liver function, and who either have not been previously treated with drug therapy for their hepatitis C or who have failed such treatment. Victrelis is approved for use in combination with peginterferon alfa and ribavirin.

The safety and effectiveness of Victrelis was evaluated in two phase 3 clinical trials with 1,500 adult patients. In both trials, two-thirds of patients receiving Victrelis in combination with pegylated interferon and ribavirin experienced a significantly increased sustained virologic response (i.e., the hepatitis C virus was no longer detected in the blood 24 weeks after stopping treatment), compared to pegylated interferon and ribavirin alone, the current standard of care.

When a person sustains a virologic response after completing treatment, this suggests that HCV infection has been cured.

Sustained virologic response can result in decreased cirrhosis and complications of liver disease, decreased rates of liver cancer (hepatocelluar carcinoma), and decreased mortality.

“Victrelis is an important new advance for patients with hepatitis C,” said Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. “This new medication provides an effective treatment for a serious disease, and offers a greater chance of cure for some patients’ hepatitis C infection compared to currently available therapy.”

According to the U.S. Centers for Disease Control and Prevention, about 3.2 million people in the United States have chronic hepatitis C, a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure.
Most people with hepatitis have no symptoms of the disease until liver damage occurs, which may take several years.

Most liver transplants performed in the United States are due to progressive liver disease caused by hepatitis C virus infection. After the initial infection with hepatitis C virus (HCV), most people develop chronic hepatitis C. Some will develop cirrhosis of the liver over many years. Cirrhosis can lead to liver damage with complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in abdomen, infections, or liver cancer.

People can get the hepatitis C virus in a number of ways, including: exposure to blood that is infected with the virus; being born to a mother with HCV; sharing a needle; having sex with an infected person; sharing personal items such as a razor, toothbrush with someone who is infected with the virus, or from unsterilized tattoo or piercing tools.

Victrelis is a pill taken three times a day with food. The therapy is part of a class of drugs referred to as protease inhibitors, which work by binding to the virus and preventing it from multiplying.

The most commonly reported side effects in patients receiving Victrelis in combination with pegylated interferon and ribavirin include fatigue, low red blood cell count (anemia), nausea, headache and taste distortion (dysgeusia).

Victrelis is marketed by Whitehouse Station, N.J.-based Merck.

For more information:

FDA: Approved Drugs: Questions and Answers 
FDA: What’s New at FDA in Hepatitis

FDA: Hepatitis C Tests

CDC: Hepatitis C Information for the Public

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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.

Entereg By Adolor Corporation, Approved By FDA To Help Restore Bowel Function Following Surgery

FOR IMMEDIATE RELEASE May 20, 2008

Media Inquiries: Rita Chappelle, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Approves Entereg to Help Restore Bowel Function Following Surgery

The U.S. Food and Drug Administration approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses.

"Patients who have undergone abdominal surgery and are on pain medications often experience problems eliminating waste," said Joyce Korvick, M.D., deputy director, Division of Gastroenterology Products. "Entereg will help accelerate their recovery, improve bowel function, and get these patients back on a normal diet. As with all FDA-approved products, the agency will monitor Entereg throughout its life cycle."

FDA is approving Entereg with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh the risks. The REMS will include limits on dispensing of the drug.

In approving Entereg, FDA determined that a REMS is necessary to ensure that the benefits of Entereg outweigh its risks. The REMS will include restricting Entereg to inpatient use only, requiring that hospitals be specially certified, distribution of educational materials to health care professionals, and regular assessments of the effectiveness of the REMS.

Following major abdominal surgery, some patients develop a condition known as postoperative ileus (POI). POI is a disorder that causes temporary impairment of the gastrointestinal (GI) tract's motility, or the ability of the intestines to push out waste products (not a complete blockage of the GI tract), following surgery. POI can be a by-product of a patient taking opioid pain relievers, like morphine, prescribed after surgery which can slow or inhibit normal motility. Entereg works by blocking opioid effects in the bowel.

The recommended dose for Entereg is one 12 milligram (mg) capsule given just prior to surgery and then another 12 mg dose administered twice daily for up to 7 days or not to exceed 15 doses. The product will only be available to hospitals and will come in blister packs that are marked "HOSPITAL USE ONLY." Entereg is not approved for use in pediatric populations.

The safety and efficacy of Entereg in post-operative patients were demonstrated in five studies that included 2,177 patients, of whom 1,096 received Entereg and 1,081 received placebo. Bowel recovery times ranged from 10 to 26 hours shorter for Entereg-treated patients compared to placebo-treated patients in the five studies. The most common side effects reported were low blood calcium levels, anemia and gastrointestinal problems, including constipation, dyspepsia (heartburn) and flatulence (excess bowel gas).

FDA has reviewed a 12-month study of Entereg in patients treated with opioid medications for chronic pain. In this study, there were more reports of myocardial infarctions in patients treated with a 0.5 mg dose of Entereg twice daily, compared with placebo-treated patients. This imbalance has not been observed in other studies of Entereg, including studies in patients undergoing bowel resection surgery who took 12 mg of Entereg, twice daily for up to seven days. A causal relationship with Entereg and myocardial infarction has not been established.

Consumers and health care professionals are encouraged to report adverse events to FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/how.htm.

Adolor Corporation, the manufacturer of Entereg, is based in Exton, PA. Adolor and GlaxoSmithKline, London, England, are collaborating on the development and marketing of Entereg.

Tags: FDA News, Drug Approval, Entereg, alvimopan, Gastroenterology, postoperative ileus, POI, Adolor Corporation

Generic (Requip,)Ropinirole, For Treatment of Restless Legs Syndrome Approved By FDA

The U.S. Food and Drug Administration has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome.

Ropinirole hydrochloride tablets have been approved in the following dosages: 0.25 milligram, 0.5 milligram, 1 milligram, 2 milligram, 3 milligram, and 4 milligram.

"This generic drug approval is an example of the FDA's efforts to increase access to safe and effective generic drugs as soon as the law permits," said Gary J. Buehler, director of the FDA's Office of Generic Drugs.

The following companies have received approval to market ropinirole hydrochloride tablets: Roxane Laboratories Inc., Teva Pharmaceuticals USA, Par Pharmaceuticals Inc., and Mylan Pharmaceuticals Inc.

The labeling of the generic versions of ropinirole hydrochloride may differ from that of Requip because some uses of the drug are protected by patents. In addition to treating Restless Legs Syndrome, Requip is also FDA-approved to treat symptoms of Parkinson's disease. The generic products are not approved for treatment of Parkinson's disease because this indication is protected by patent. Manufacturers of the generic drugs may seek approval for that use once the patent for the Parkinson's disease indication expires later this month.

The generic ropinirole hydrochloride tablets will have the same safety warnings as Requip, cautioning about patient reports of falling asleep while engaged in activities of daily living, including while driving. Although many of these patients reported sleepiness while on the drug, some patients perceived that they had no warning signs and believed that they were alert immediately prior to falling asleep. Some of these events have been reported as late as one year after the start of treatment.

For information:

Drugs@FDA
www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Consumer Education: Generic Drugs
www.fda.gov/cder/consumerinfo/generic_text.htm

GridTags: FDA Approval, Drug Approval, Requip, ropinirole hydrochloride, Restless Legs Syndrome, RLS, Roxane Laboratories Inc., Teva Pharmaceuticals USA, Par Pharmaceuticals Inc., Mylan Pharmaceuticals Inc

FDA Approves First Drug to Treat PKU (Phenylketonuria)

FDA has approved the first drug to treat phenylketonuria (PKU), which is a genetic disorder that affects one in about 15 thousand births in the U.S. The drug, called Kuvan (sapropterin dihydrochloride) was developed by BioMarin Pharmaceutical in partnership with Merck.

Those with PKU cannot metabolize phenylalanine, which is an amino acid found naturally in many foods. Normally, phenylalanine metabolism is controlled by the enzyme phenylalanine hydroxylase. In PKU patients, this enzyme does not function properly. That causes high blood levels of phenylalanine, which can lead to mental retardation, behavioral abnormalities, seizures and other neurological complications.

Kuvan increases the activity of phenylalanine hydroxylase in those PKU patients who have some residual functioning of this enzyme. This leads to improved breakdown and lower blood levels of phenylalanine. Still, in order for the drug to be most effective, patients on Kuvan must be on a phenylalanine-restricted diet, and blood levels must be monitored frequently.

The safety and efficacy of Kuvan was demonstrated in four short-term studies of 579 PKU patients. In addition, the manufacturer will establish general disease registries for PKU to help track clinical results and monitor any adverse effects.

Additional Information:

FDA Press Release. FDA Approves Kuvan for Treatment of Phenylketonuria (PKU). December 13, 2007.
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01761.html

tag: Drug Approval, FDA, PKU, Phenylketonuria, BioMarin Pharmaceutical, Merck, Kuvan, sapropterin dihydrochloride, phenylalanine,

FDA Approves New Drug Application (NDA) for LEVOleucovorin

FDA has approved new drug application (NDA) for LEVOleucovorin, Spectrum’s first proprietary oncology drug
proprietary drug Levoleucovorin for injection (formerly known as ISO-Vorin, a novel folate analog, is the first new oncology drug approved by the FDA in 2008.

Proprietary Brand Names Submitted by Company Currently Under Review by FDA.

LEVOleucovorin Has Been Marketed with Success in Europe and Japan by Wyeth, Sanofi and Others.
Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI) today announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for Levoleucovorin for Injection. It is indicated after high-dose methotrexate therapy in patients with osteosarcoma, and to diminish the toxicity and counteract the effects of impaired methotrexate elimination or inadvertent overdose of folic acid antagonists. LEVOleucovorin is the only commercially available formulation comprised only of the pharmacologically active enantiomer of leucovorin (Levoleucovorin or (6S)-leucovorin). The Company currently expects its commercial launch by June 2008.
tag: FDA, Drug Approval, Spectrum Pharmaceuticals, Levoleucovorin, leucovorin, folate analog, oncology drug

Nexium Approved for Use in Children Ages 1-11 Years

FOR IMMEDIATE RELEASE February 28, 2008

Media Inquiries: Rita Chappelle, 301-827-6246 Consumer Inquiries: 888-INFO-FDA

FDA Approves Nexium for Use in Children Ages 1-11 Years

The U.S. Food and Drug Administration approved Nexium (esomeprazole magnesium) for short-term use in children ages 1-11 years for the treatment of gastroesophageal reflux disease (GERD). The agency approved Nexium in two forms, a delayed-release capsule and liquid form. Nexium is approved in 10 milligrams (mg) or 20 mg daily for children 1-11 years old compared to 20 mg or 40 mg recommended for pediatric patients 12 to 17 years of age.

"This approval provides important information for appropriate dosing for children ages 1-11 years with GERD," said Julie Beitz, M.D., director of the FDA's Office of Drug Evaluation III in the Center for Drug Evaluation and Research. "Children prescribed this drug should be monitored by their physicians for any adverse drug reactions."

Nexium is part of a class of drugs known as proton pump inhibitors (PPIs). PPIs decrease the amount of acid produced in the stomach and help heal erosions in the lining of the esophagus known as erosive esophagitis.

FDA approved the use of Nexium in patients 1 to 11 years for short-term treatment of GERD based upon the extrapolation of data from previous study results in adults to the pediatric population, as well as safety and pharmacokinetic studies performed in pediatric patients. In one study, 109 patients 1-11 in age, diagnosed with GERD, were treated with Nexium once-a-day for up to eight weeks to evaluate its safety and tolerability. Most of these patients demonstrated healing of their esophageal erosions after eight weeks of treatment.

The most common adverse reactions in children treated with Nexium were headache, diarrhea, abdominal pain, nausea, gas, constipation, dry mouth and sleepiness. The safety and efficacy of Nexium has not been established in children less than one year of age.

Nexium is manufactured by AstraZeneca of Wilmington, DE.

tag: FDA Approval, Drug Approval, Nexium, esomeprazole magnesium, gastroesophageal reflux disease, GERD, CDER, erosive esophagitis, AstraZeneca

New and Generic Drug Approvals, February 21, 2008

• New and Generic Drug Approvals
  • ARESTIN (minocycline hydrochloride) Microspheres, OraPharma Inc., Labeling Revision
  • Avelox (moxifloxacin hydrochloride) Tablets, Bayer Pharma, Labeling Revision
  • Avelox (moxifloxacin hydrochloride in NaCl) I.V., Bayer Pharma, Labeling Revision
  • Irinotecan Hydrochloride Injection, Watson Labs, Approval
  • Lexiva (fosamprenavir calcium) Tablets, GlaxoSmithKline, Labeling Revision
  • Pramipexole Dihydrochloride Tablets, Barr Labs, Approval
  • Reyataz (atazanavir sulfate) Capsules, Bristol-Myers Squibb, Labeling Revision
  • Ultram ER Extended-Release Tablets, Biovail Labs, Labeling Revision

tag: FDA Approval, Drug Approval, Ultram, Reyataz, Pramipexole, Lexiva, Irinotecan, Avelox, Avelox, ARESTIN

Generic Fosamax Approved By FDA

FOR IMMEDIATE RELEASE February 6, 2008

Media Inquiries: Susan Cruzan, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

Generic Fosamax Approved

The U.S. Food and Drug Administration today approved the first generic versions of Fosamax (alendronate sodium tablets), used to treat osteoporosis, a condition that causes thinning and weakening of a person's bones.

Teva Pharmaceuticals USA, North Wales, Pa., was approved to manufacture alendronate sodium tablets in three once-daily dosing strengths (5 milligrams, 10 milligrams, and 40 milligrams) and two once-weekly dosing strengths (35 milligrams and 70 milligrams). Barr Laboratories, Inc., Montvale, N.J., was approved to manufacture a 70 milligrams once-weekly dose of the drug.

"The FDA works to assure the safety and efficacy of generic drugs through a rigorous scientific and regulatory process," said Gary J. Buehler, R.Ph, director of the FDA's Office of Generic Drugs. "These approvals will provide generic options for patients who take Fosamax for their osteoporosis."
Fosamax is among the top 100 most frequently dispensed drugs in the United States, according to the trade magazine Drug Topics.

Generic drug manufacturers must demonstrate that a generic drug has the same active ingredient, dosage form, strength, route of administration, quality and performance characteristics, among other things, as the approved brand-name drug.

The labeling of the generic alendronate sodium tablets may differ from that of Fosamax because some portions of the labeling are protected by patents and exclusivity.

For more information visit FDA's Office of Generic Drugs www.fda.gov/cder/consumerinfo/generic_equivalence.htm

#

tag: Generic Fosamax, FDA Approval, Drug Approval, alendronate sodium tablets, Barr Laboratories, Generic Drugs, Fosamax

FDA Approves New HIV Drug After Priority Review

FOR IMMEDIATE RELEASE January 18, 2008

Media Inquiries: Christopher Kelly, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Approves New HIV Drug After Priority Review
Etravirine tablets used in combination with other antiretroviral agents

The U.S. Food and Drug Administration today approved etravirine tablets for the treatment of HIV infection in adults who have failed treatment with other antiretrovirals.

Etravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that helps to block an enzyme which HIV needs to multiply. The drug was approved to be used in combination with other anti-HIV medications. Sold under the trade name Intelence, etravirine received a priority review by the FDA.

Development of etravirine was triggered by the observations of in vitro anti-HIV activity of etravirine against mutant, NNRTI-resistant HIV strains.

"This is another significant new product for many HIV-infected patients who are NNRTI –resistant and whose infections are not responding to currently available medications," said Debra B. Birnkrant, M.D., director of the FDA's Division of Antiviral Products.

When used with other active anti-HIV medicines and when taken as prescribed, etravirine reduces the amount of HIV in the blood and increases white blood cells that help fight off other infections. In addition, etravirine may reduce the risk of death or infections that can occur with a weakened immune system.

The FDA's approval of etravirine is based primarily on data from 599 adults who received etravirine in two randomized, double-blind, placebo-controlled trials. After 24 weeks of treatment, more of the patients who received etravirine along with background therapy experienced reductions in the level of HIV in their blood than did those who received a placebo and background therapy.

The most common adverse events reported were rash and nausea. Patients developing a rash while taking etravirine should contact their doctor. To avoid drug interactions, patients starting etravirine treatment should tell their prescribers and pharmacists about all the medications they take. Information about drug interactions is contained in the etravirine package insert.

In the overall development program for etravirine, rare cases of serious skin reactions such as Stevens-Johnson syndrome and erythema multiforme were reported. Patients taking etravirine may develop infections, including opportunistic infections or other conditions that may develop in patients living with HIV infection. The long-term effects of etravirine are not known, and its safety and effectiveness in children ages 16 years and younger has not been studied.

Etravirine also has not been studied in pregnant women. Women who are taking HIV medications when they become pregnant are advised to consult their physician or other health care professional about use of etravirine during pregnancy and about registering with the Antiviral Pregnancy Registry.

Etravirine is distributed by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., based in Bridgewater, N.J.

FDA and its work in HIV/AIDS

tag: FDA Approval, Drug Approval, HIV Drug, antiretroviral agent, Etravirine, NNRTI, Intelence, AIDS Drug, Ortho Biotech Products, Tibotec Therapeutics,

Real-Time Test for Respiratory Viruses Cleared By FDA For Marketting.

FOR IMMEDIATE RELEASE January 18, 2008

Media Inquiries: Heidi Rebello, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Clears for Marketing Real-Time Test for Respiratory Viruses
Molecular biology device detects four viruses, including influenza; results available in about 3 hours

The U.S. Food and Drug Administration has cleared for marketing a test that simultaneously detects four common respiratory viruses, including the flu, in a patient’s respiratory secretions. The ProFlu+ test provides results in as few as three hours. Other diagnostic tests for respiratory viruses are fast but not as accurate or are accurate but not as rapid.

The real-time test employs a multiplex platform that allows several tests to be processed using the same sample to detect influenza A virus, influenza B virus, and respiratory syncytial virus A and B (RSV).

These viruses can cause influenza, an infection of the airways called bronchiolitis, and pneumonia. All are among the leading causes of lower respiratory tract infections.

“Antiviral drugs are most effective when initiated within the first two days of symptoms,” said Daniel Schultz, M.D., director of FDA’s Center for Devices and Radiological Health. “This new test, which is part of the new era of molecular medicine, can help the medical community quickly determine whether a respiratory illness is caused by one of these four viruses and initiate the appropriate treatment.”

ProFlu+ uses a molecular biology process to isolate and amplify viral genetic material present in secretions taken from the back of the throat in patients.

While ProFlu+ is faster than conventional tests, it is specific to the four viruses, and is more accurate when used with other diagnostics, such as patient data, bacterial, or viral cultures, and X-rays, in diagnosing a patient. Positive results do not rule out other infection or co-infection and the virus detected may not be the specific cause of the disease or patient symptoms.

An estimated 5 percent to 20 percent of the U.S. population contracts influenza each year, resulting in more than 200,000 hospitalizations and up to 36,000 deaths. Influenza A, one of three types of human influenza, is the most severe and has been the cause of major epidemics. Influenza B is less severe than influenza A.

Bronchiolitis usually affects children under the age of 2, and is a common, sometimes severe illness. A common cause of the disease is RSV.

Pneumonia is a common illness that affects millions of people each year in the United States and is usually caused by an infection. People most at risk are older than 65 or younger than 2 years of age, or already have health problems.

ProFlu+ is manufactured by Prodesse, Inc. of Milwaukee.

tag: FDA, Drug Approval, influenza, ProFlu+ test, influenza A virus, influenza B virus, syncytial virus, bronchiolitis, pneumonia, Prodesse,

Crohn's Disease Drug Tysabri Approved By FDA to Treat Moderate-to-Severe Crohn's Disease

FOR IMMEDIATE RELEASE January 14, 2008

Media Inquiries: Rita Chappelle, 301-827-6246 Consumer Inquiries: 888-INFO-FDA

FDA Approves Tysabri to Treat Moderate-to-Severe Crohn's Disease
Drug currently approved for use in treating some forms of multiple sclerosis

The U.S. Food and Drug Administration has approved Tysabri (natalizumab) for the treatment of moderate-to-severe Crohn's disease in patients with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional Crohn's disease therapies. Crohn's disease patients using the drug must be enrolled in a special restricted distribution program called the Crohn's Disease–Tysabri Outreach Unified Commitment to Health (CD TOUCH) Prescribing Program.

The approval is consistent with an agency advisory committee recommendation to approve Tysabri for use in Crohn's patients. Tysabri was approved by the FDA in June 2006 to treat relapsing forms of multiple sclerosis.

Crohn's disease is a chronic, inflammatory bowel disease that affects both men and women. There is no cure. Crohn's can cause diarrhea, fever, rectal bleeding, malnutrition, narrowing of the intestinal tract, obstructions, abscesses, cramping, and abdominal pain. The disease also can lead to abnormal connections (fistulas) leading from the intestine to the skin or internal organs. Its cause is unknown. There are more than 1 million people with Crohn's disease worldwide.

"The addition of Tysabri to the treatment options for sufferers of Crohn's disease is important, but one that carries serious risks," said Daniel Shames, deputy director of the Office for Drug Evaluation III and director of the Division of Products for the Center for Drug Evaluation and Research. "Health care providers must carefully monitor patients for these risks. The CD-TOUCH Prescribing Program will aid FDA in monitoring this drug through its life cycle."

Tysabri carries a boxed warning for progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection that affects the brain and can lead to death or severe disability.

Other serious adverse events that have occurred in Tysabri-treated patients include hypersensitivity reactions, such as anaphylaxis and liver injury. Serious opportunistic and other atypical infections have been observed in patients receiving immunosuppressants while on Tysabri, and Tysabri should generally not be used in patients receiving immunosuppressants. Serious herpes infections have also been observed. Common side effects include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain, and rash.

Because of these risks, patients, prescribers, pharmacies, and infusion centers must all be enrolled in CD-TOUCH and agree to comply with the company's strict monitoring guidelines. Additionally, they must participate in an extensive educational program designed to inform people about the risks of Tysabri treatment. Tysabri is administered intravenously by trained professionals at infusion centers.

Under CD-TOUCH, health care providers evaluate Crohn's disease patients after three months of treatment to determine if they have improved on Tysabri. If not, patients should discontinue treatment. People who are taking steroids for Crohn's disease should begin tapering steroid doses while on Tysabri. Treatment should be discontinued if steroids cannot be fully tapered within six months.

Tysabri is manufactured by Biogen Idec of Cambridge, Massachusetts and Elan of Dublin, Ireland. Both companies have agreed to conduct long-term surveillance for safety, including monitoring and expedited reporting of PML infections, other serious opportunistic infections, malignancies, and deaths in people treated with Tysabri.

For more information on Crohn's Disease, visit:

Crohn's Disease–National Institute of Diabetes and Digestive and Kidney Diseases
www.digestive.niddk.nih.gov/ddiseases/pubs/crohns/index.htm

tag: FDA, Drug Approval, Tysabri, Crohn's Disease, multiple sclerosis, natalizumab, CD TOUCH, Gastroenterology, leukoencephalopathy, anaphylaxis, Biogen Idec, Elan of Dublin,

Voluven Approved By FDA To Treat Serious Blood Volume Loss following Surgery

FOR IMMEDIATE RELEASE December 27, 2007

Media Inquiries: Peper Long, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Approves Voluven to Treat Serious Blood Volume Loss following Surgery

This press release contains a revision posted Dec. 28, 2007, to correct the name of the manufacturer of the product Hespan.

The U.S. Food and Drug Administration today approved Voluven, an intravenous solution that prevents and treats a dangerous loss of blood volume, a condition that sometimes occurs during and after surgery.

Significant blood losses can cause a rapid drop in the volume of red blood cells and plasma circulating through the body. This can lead to shock, which is potentially fatal. Blood volume expanders are commonly administered to quickly restore some of the lost volume so that remaining red blood cells can continue to deliver needed oxygen to the body's tissues.

Voluven contains a synthetic starch that does not dissolve in water. It is made by linking individual starch molecules together and combining them with a salt solution, similar to the salt concentration typically found in blood. Voluven expands the volume of blood plasma – the liquid portion of the blood – and thus draws fluid into small blood vessels known as capillaries.

"Massive blood loss is a life-threatening problem. Approval of Voluven provides clinicians with an alternative blood volume product that is safe and effective in a wide range of age groups," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research.

In clinical trials, Voluven was compared to other approved blood volume expanders. During orthopedic surgery, Voluven was as safe and effective in expanding blood volume as Hespan, an approved starch solution.

In newborns and infants undergoing major surgery, Voluven was as safe and effective as an equivalent volume of another expander containing albumin, a protein found in the blood. In other trials conducted overseas, Voluven was as safe as other blood volume expanders used in those countries in patients ranging in age from less than two years to 75 years who were undergoing a variety of surgical procedures.

The most common side effects from Voluven were nausea and itching.

Voluven is not recommended for the following:

• patients with known abnormal sensitivity to the synthetic starch used in the product,
• patients experiencing fluid overload
• patients with kidney failure not related to low blood volume
• patients on dialysis
• patients with severe increases in blood levels of sodium or chloride
• patients with bleeding inside the head

Voluven was not studied in patients with sepsis, an infection of the blood. A post-market clinical trial involving patients with sepsis is planned.

Voluven (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) is manufactured by Fresenius Kabi, Bad Homburg, Germany. Hespan is manufactured by B. Braun Medical Inc. of Bethlehem, Penn.
Tags: FDA, DRUGS,Voluven,