CDERNEW-TEXT 9/6/2007
Thursday, September 6, 2007
September 6, 2007
FDA approves the first generic versions of Coreg (carvedilol). FDA News
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01695.html
FDA approves Somatuline Depot (lanreotide acetate injection) for the
treatment of acromegaly. FDA News
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01692.html
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Amlodipine Besylate Tablets, Actavis, Approval
Carvedilol Tablets, Actavis Elizabeth, Approval
Carvedilol Tablets, Apotex Corp., Approval
Carvedilol Tablets, Caraco Pharma, Approval
Carvedilol Tablets, Dr. Reddy's Labs, Approval
Carvedilol Tablets, Mylan Pharma, Approval
Carvedilol Tablets, Ranbaxy, Approval
Carvedilol Tablets, Sandoz Inc., Approval
Carvedilol Tablets, Taro Pharma, Approval
Carvedilol Tablets, Teva Pharma, Approval
Carvedilol Tablets, Watson Labs, Approval
Carvedilol Tablets, Zydus Pharma, Approval
Ciclopirox Topical Solution, Watson Labs, Tentative Approval
Clarithromycin Oral Suspension, Sandoz Inc., Approval
Differin (adapalene) Gel, Galderma Labs, Manufacturing Change or
Addition
Duetact (pioglitazone HCl + glimepiride) Fixed-dose Combination Tablets,
Takeda Global, Package Change
Hydrochlorothiazide Tablets, Cadista Pharma, Approval
MDP Multidose Utilipak (Technetium Tc99m Medronate) Injection, GE
HealthCare, Labeling Revision
Mucinex (guaifenesin) Extended Release Bi-layer Tablets, Adams
Respiratory Therapeutics, Formulation Revision
Mucinex D (guaifenesin, pseudoephedrine HCl and 1200 mg guaifenesin/120
mg pseudoephedrine HCl) Extended Release Bi-layer Tablets, Adams
Respiratory Therapeutics, Formulation Revision
Mucinex DM (guaifenesin, dextromethorphan HBr and guaifenesin
dextromethorphan HBr) Extended Release Bi-layer Tablets, Adams
Respiratory Therapeutics, Formulation Revision
Ofloxacin Otic Solution, Alcon, Tentative Approval
Omniscan Injection, GE HealthCare, Labeling Revision
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posted by Mags @ 3:55 PM,
