Health and Beauty: 27/02/08

What's New at CBER Update

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Information Pertaining to Labeling Revision for ProQuad
Posted: 2/27/2008

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What's New at CBER Update

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Supplement Approval: Measles, Mumps, Rubella and Varicella Virus Vaccine Live (ProQuad) - Package Insert Revisions
Posted: 2/27/2008, Approval Date: 2/27/2008

Testing HCT/P Donors for Relevant Communicable Disease Agents and Diseases - Update
Posted: 2/27/2008

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FDA Approves New Orphan Drug for Treatment of Rare Inflammatory Syndromes

FDA Approves New Orphan Drug for Treatment of Rare Inflammatory Syndromes
Wed, 27 Feb 2008 15:57:00 -0600

The U.S. Food and Drug Administration today approved a drug to help ease the suffering faced by those with certain chronic inflammatory diseases. Arcalyst (rilonacept, an Interleukin-1 blocker) is now approved for the long term treatment of two Cryopyrin-Associated Periodic Syndromes (CAPS) disorders: Familial Cold Auto-Inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).

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FDA MedWatch - FDA MedWatch - Tysabri (natalizumab) - Reports Of Clinically Significant Liver Injury

Biogen Idec, Elan and FDA notified healthcare professionals of reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose of Tysabri. The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant in some patients. Tysabri should be discontinued in patients with jaundice or other evidence of significant liver injury. Physicians should inform patients that Tysabri may cause liver injury.

Read the complete 2008 MedWatch Safety Summary, including a link to the manufacturer's Dear Healthcare Professional Letter and prescribing information for Tysabri at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tysabri

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U.S. Food & Drug Administration (FDA) CBER Recalls, Withdrawals, Field Corrections & Notifications Update

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Recall of Thymoglobulin [Anti-thymocyte Globulin (Rabbit)]
Posted: 2/27/2008, Recall Date: 2/11/2008

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What's New at CBER Update

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Recall of Thymoglobulin [Anti-thymocyte Globulin (Rabbit)]
Posted: 2/27/2008, Recall Date: 2/11/2008

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FDA Warning Letters Update

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CDER New 2/26/2008

Center for Drug Evaluation and Research, U.S. Food and Drug Administration

February 26, 2008

CDER Key Officials
Drug Shortages
- Drug to be Discontinued: Teslac (testolactone tablets, USP) 50mg tablets
New and Generic Drug Approvals
- Amiodarone Hydrochloride Injection, Hikma Farmaceutia, Approval
- Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, Teva Pharma, Approval
- PREZISTA (darunavir) Tablets, Tibotec Inc., Formulation Revision
- Restoril (temazepam) Tablets, Mallinckrodt Inc., Labeling Revision
- VIAGRA (sildenafil citrate) Tablets, Pfizer Inc., Labeling Revision

CDER Home Page | Contact CDER | FDA Home Page | HHS Home Page

U.S. Food and Drug Administration
Center for Drug Evaluation and Research
1-888-INFO-FDA (1-888-463-6332)

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U.S. Food & Drug Administration (FDA) CBER Recalls, Withdrawals, Field Corrections & Notifications Update

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Recall of Hymenoptera (Honey Bee) Venom Products
Posted: 2/27/2008; Recall Date: 1/29/2008

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What's New at CBER Update

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Recall of Hymenoptera (Honey Bee) Venom Products
Posted: 2/27/2008; Recall Date: 1/29/2008

FDA 101: Human Gene Therapy
Posted: 2/27/2008

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What's New at CBER Update

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Vacancy Announcement - Regulatory Information Specialist, CTB/DCCA/OCTMA
Posted: 2/26/2008

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