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- The following 13 manufacturers have received FDA approval for zolpidem tartrate tablets: Mylan Pharmaceuticals Inc., TEVA Pharmaceuticals USA, Roxane Laboratories Inc., Watson Laboratories Inc., Ranbaxy Laboratories Ltd., Dr. Reddy's Laboratories Ltd., Apotex Inc., Synthon Pharmaceuticals Inc., Genpharm Inc., Mutual Pharmaceutical Company Inc., Caraco Pharmaceutical Laboratories Ltd., Carlsbad Technology Inc., and Lek Pharmaceuticals.
- No Other Systane® Formulations Affected by Recall FOR IMMEDIATE RELEASE -- FORT WORTH, Texas – December 14, 2006 – Alcon Laboratories, Inc., a...
- Information for Healthcare Professionals Exenatide (marketed as Byetta) This information is not current. The issues described in this...
- Selected Enforcement Actions on Unapproved Drugs Injectable Colchicine Products Hydrocodone Drug Products ...
- Drugs Marketed in the United States That Do Not Have Required FDA Approval The Federal Food, Drug, and Cosmetic Act generally requires that drugs...
- CDER Sponsored Workshops and Meetings Upcoming PDA/FDA Co-Sponsored Conference Series on Quality Systems , Bethesda, MD, Nov., 1-2, 2007; Dublin,...
- International Conference on Harmonization (ICH) in the Office of Pharmaceutical Science (OPS) ICH is the shortened name for The International Conference on Harmonisation...
- Clarification of Recent FDA Initiatives Affecting OTC Drugs FDA recently announced implementation of two statutory amendments affecting over-the-counter (OTC) drug products. ...
- Early Communication about an Ongoing Data Review for Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor) This...
- FDA Approves Sorafenib (Nexavar) for the Treatment of Unresectable Hepatocellular Carcinoma On November 16, 2007, the U.S. Food and Drug Administration approved sorafenib...
- Division of Applied Pharmacology Research Research Programs Federal Research Center Life Sciences Building 64, HFD-910 10903 New Hampshire Avenue Silver Spring, MD 20993 ...
- Viagra (sildenafil citrate) Information FDA has new safety information about this drug, please see http://www.fda.gov/cder/consumerinfo/viagra/default.htm The NAION...
- FDA Public Health Advisory Erythropoiesis-Stimulating Agents (ESAs) Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp) FDA has approved...
- FDA Drug Safety Podcasts Erythropoiesis-Stimulating Agents (ESAs) Full Version FDA Drug Safety Podcasts Home Podcasts by Date Podcasts by Topic Podcast Archives 2007 --> What...
- FDA Public Health Advisory Erythropoiesis-Stimulating Agents (ESAs) Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp) ...
- Guidances We Develop and Enforcement Information Contents On This Page Regulatory & Scientific Guidances Specific Regulatory Initiatives ...
- FDA Grants Accelerated Approval to Nilotinib (Tasigna) to Treat Leukemia On October 29, 2007, the U. S. Food and Drug Administration granted accelerated approval to...
- Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs As part of the cGMP initiative announced in August of 2002, and to...
- Historical Information on Viagra (sildenafil citrate) The FDA approved Viagra on March 27, 1998. Viagra is the first oral pill to treat...
- Exenatide (marketed as Byetta) Information FDA ALERT [10/2007]: FDA has reviewed 30 postmarketing reports of acute pancreatitis in patients taking Byetta, a drug...
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