Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Sat, 9 Aug 2008 02:31:42 -0500 (CDT)
Subject: CDER New 8/7 - 8/2008
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August 8, 2008
- CDER Manual of Policies and Procedures (MaPP) 4641.3R Outside Activities
- FDA issues an Information for Healthcare Professionals sheet for Amiodarone and Simvastatin. Drug Information.
- Genomics at FDA (updated)
- New and Generic Drug Approvals
- Alendronate Sodium Tablets, Apotex, Inc., Approval
- Alendronate Sodium Tablets, Aurobindo Pharma, Ltd., Approval
- Alendronate Sodium Tablets, Barr Laboratories, Inc., Labeling
- Alendronate Sodium Tablets, Cobalt Laboratories, Inc., Approval
- Alendronate Sodium Tablets, Dr. Reddy's Laboratories, Ltd., Approval
- Alendronate Sodium Tablets, Dr. Reddy's Laboratories, Ltd., Approval
- Alendronate Sodium Tablets, Mylan Pharmaceuticals, Inc., Approval
- Alendronate Sodium Tablets, Watson Laboratories, Inc., Approval
- Aleve Cold and Sinus (naproxen sodium and pseudoephedrine hydrochloride) Extended-Release Tablets, Bayer Healthcare, LLC, Labeling Revision
- Cleviprex (clevidipine butyrate) Injectable Emulsion, The Medicines Co., Approval
- Eplerenone Tablets, Sandoz, Inc., Approval
- Retisert (fluocinolone acetonide) Intravitreal Implant, Bausch & Lomb, Inc., Efficacy Supplement with Clinical Data to Support
- Symlin (pramlintide acetate) Subcutaneous Injection, Amylin Pharmaceuticals, Inc. Labeling Revision
- Viagra (sildenafil citrate) Tablets, Pfizer, Inc., Labeling Revision
- Pediatric Research Equity Act (PREA) Labeling Changes (updated)
August 7, 2008
- BPCA/Pediatric Exclusivity Statistics:
- Pediatric Exclusivity Granted (updated)
- Written Requests Issued (updated)
- Written Requests Statistics (updated)
- Drugs@FDA Downloadable Data Files (updated)
- New and Generic Drug Approvals
- Adenosine Injection, Teva Parenteral Medicines, Approval
- Advair HFA (fluticasone propionate and salmeterol xinafoate) Inhalation Aerosol, GlaxoSmithKline, Control Supplement
- Cardene (nicardipine hydrochloride) Injection, EKR Therapeutics, Inc., Formulation Revision
- Ceftriaxone (ceftriaxone sodium) Intramuscular I.V. Injection, Aurobindo Pharma Ltd., Approval
- Diovan HCT (valsartan and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., New or Modified Indicatiion
- Divalproex Sodium Delayed-Release Tablets, Wockhardt USA, Inc., Approval
- Dorzolamide Hydrochloride Ophthalmic Solution, Apotex Corp., Tentative Approval
- Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, Apotex Corp., Tentative Approval
- Lupron Depot-Ped (leuprolide acetate) Injection, Abbott Laboratories, Labeling Revision
- Ranitidine (ranitidine hydrochloride) Tablets, Wockhardt USA, Inc., Approval
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Sat, 9 Aug 2008 10:02:40 -0500 (CDT)
Subject: FDA MedWatch - Simvastatin Used With Amiodarone - Risk of rhabdomyolysis when simvastatin is used with amiodarone
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FDA notified healthcare professionals of the risk of muscle injury, rhabdomyolysis, which can lead to kidney failure or death, when simvastatin is used with amiodarone. This risk is dose-related and increases when a dose of simvastatin greater than 20 mg per day is given with amiodarone. Although a revision of the simvastatin labeling in 2002 described an increased risk of rhabdomyolysis when amiodarone is taken with simvastatin doses greater than 20 mg daily, FDA continues to receive reports of rhabdomyolysis in patients treated concurrently with amiodarone and simvastatin. Prescribers should be aware of the increased risk of rhabdomyolysis when simvastatin is prescribed with amiodarone, and they should avoid doses of simvastatin greater than 20 mg per day in patients taking amiodarone.
Read the complete MedWatch safety summary, including links to the FDA Drug Information page, Information for Healthcare Professionals sheet, and labels (Prescribing Information) for simvastatin and amiodarone products, at
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Simvastatin
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