martes, 7 de junio de 2011

What's New on the FDA Drugs Site

June 3, 2011

Drug Firm Annual Registration Status (updated)
Drug Shortages: Current Drug Shortages: Acetylcysteine Inhalation Solution (updated)
Drug Shortages: Current Drug Shortages: Ammonium Chloride Injection (updated)
Drug Shortages: Current Drug Shortages: Bleomycin Injection (updated)
Drug Shortages: Current Drug Shortages: Desmopressin Injection (updated)
Drug Shortages: Current Drug Shortages: Foscarnet Sodium Injection (updated)
Drug Shortages: Current Drug Shortages: Fosphenytoin Sodium Injection (updated)
Drug Shortages: Current Drug Shortages: Furosemide Injection (updated)
Drug Shortages: Current Drug Shortages: Intravenous Fat Emulsion (updated)
Drug Shortages: Current Drug Shortages: Lorazepam Injection (updated)
Drug Shortages: Current Drug Shortages: Metoclopramide injection (updated)
Drug Shortages: Current Drug Shortages: Multi-Vitamin Infusion (Adult and pediatric) (updated)
Drug Shortages: Current Drug Shortages: Procainamide HCL Injection (updated)
Drug Shortages: Current Drug Shortages: Propofol Injection (updated)
Drug Shortages: Current Drug Shortages: Sodium Chloride 23.4% (updated)
Drug Shortages: Current Drug Shortages: Sodium Chloride 14.6% Injection (updated)
Drug Shortages: Current Drug Shortages: Sodium Phosphate Injection (updated)
Drug Shortages: Current Drug Shortages: Tromethamine (updated)
Drug Shortages: Current Drug Shortages: Vecuronium Injection(updated)
Drug Shortages: Current Drug Shortages: Vincristine Sulfate Injection(updated)
MedWatch Safety Alert: Aidapak Services Repackaged Pharmaceuticals: Recall - Potential Cross Contamination with Beta Lactam Products
Office of Translational Sciences (updated)
New and Generic Drug Approvals

June 3, 2011

Banzel (rufinamide) Oral Tablets, Eisai, Inc., Labeling Revision
Banzel (rufinamide) Oral Suspension, Eisai, Inc., Labeling Revision
Clindamycin Hydrochloride Capsules, Matrix Laboratories Ltd., Approval
Diovan HCT (hydrochlorothiazide and valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
Donepezil Hydrochloride Tablets, Apotex Inc., Approval
Exforge (amlodipine besylate and valsartan) Tablets, Novartis Pharmaceuticals, Labeling Revision
Exforge HCT (amlodipine besylate, hydrochlorothiazide and valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
Pepcid (famotidine) Tablets, Merck & Co., Inc., Labeling Revision
Prevacid (lansoprazole) Delayed-Release Capsules, Takeda Pharmaceuticals, Labeling Revision
Prevacid (lansoprazole) Delayed-Release Orally Disintegrating Tablets, Takeda Pharmaceuticals, Labeling Revision
Retisert (fluocinolone acetonide) Implant, Bausch & Lomb, Inc., Manufacturing Change or Addition
Venlafaxine Hydrochloride Extended-Release Capsules, Mylan Pharmaceuticals, Inc., Approval
Venlafaxine Hydrochloride Extended-Release Capsules, Torrent Pharmaceuticals Ltd., Approval
Tussionex Pennkinetic (chlorpheniramine polistirex and hydrocodone polistirex) Extended-Release Oral Suspension, UCB, Inc., Approval

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