New and Generic Drug Approvals

Featured In: Regulatory News

By Federal Drug Administration Tuesday, March 9, 2010

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New and Generic Drug Approvals

Visit Drugs@FDA to search Drug Approval Reports by Month. 

March 9, 2010

  • Betaxon (levobetaxolol hydrochloride) Ophthalmic Suspension, Alcon Research, Ltd., Labeling Revision
  • ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) Sponge, Enturia Inc., Labeling Revision
  • ChloraPrep One-Step Frepp (chlorhexidine gluconate and isopropyl alcohol) Sponge, Enturia Inc., Labeling Revision
  • ChloraPrep One-Step with Tint (chlorhexidine gluconate and isopropyl alcohol) Sponge, Enturia Inc., Labeling Revision
  • Copegus (ribavirin) Tablets, Hoffmann-La Roche Inc., Labeling Revision
  • Inderide-40/25 (hydrochlorothiazide and propranolol hydrochloride) Tablets, Akrimax Pharmaceuticals, LLC, Labeling Revision
  • Inderide-80/25 (hydrochlorothiazide and propranolol hydrochloride) Tablets, Akrimax Pharmaceuticals, LLC, Labeling Revision
  • Nexium (esomeprazole magnesium) Delayed-Released Oral Solution, AstraZeneca, Labeling Revision
  • Nexium (esomeprazole magnesium) Delayed-Release Capsules, AstraZeneca, Labeling Revision
  • Nexium (esomeprazole magnesium) Delayed-Release Oral Solution, AstraZeneca, Labeling Revision
  • Nexium IV (esomeprazole sodium) Intravenous Injection, AstraZeneca, Labeling Revision
  • Tyzeka (telbivudine) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
  • Tyzeka (telbivudine) Oral Solution, Novartis Pharmaceuticals Corp., Labeling Revision
  • Vanos (fluocinonide) Topical Cream, Medicis Pharmaceutical Corp., Labeling Revision

March 5, 2010

  • Adalat (nifedipine) Extended-Release Tablets, Bayer HealthCare, Labeling Revision
  • Avelox (moxifloxacin hydrochloride) Tablets, Bayer HealthCare Pharmaceuticals, Inc., Labeling Revision
  • Avelox in Sodium Chloride 0.8% in Plastic Container (moxifloxacin hydrochloride) I.V. Injection, Bayer HealthCare Pharmaceuticals, Inc., Labeling Revision
  • ChloraPrep One-Step Sepp (chlorhexidine gluconate and isopropyl alcohol) Topical Swab, CareFusion, LLC, Labeling Revision
  • Femara (letrozole) Tablets, Novartis Pharmaceuticals Corporation, Efficacy Supplement with Clinical Data to Support
  • Fluvastatin Capsules, Teva Pharmaceuticals, Tentative Approval
  • Invega (paliperidone) Extended-Release Tablets, Johnson & Johnson Pharmaceutical, Labeling Revision
  • Levetiracetam Oral Solution, Wockhardt, Approval
  • Rapaflo (silodosin) Capsules, Watson Laboratories, Inc., Labeling Revision
  • Xifaxan (rifaximin) Tablets, Salix Pharmaceuticals, Inc., Labeling Revision
  • Zocor (simvastatin) Tablets, Merck & Co., Inc., Labeling Revision 

March 3, 2010

  • Exalgo (hydromorphone hrdrochloride) Extended-Release Tablets, ALZA Corporation, Approval
  • Fosamax (alendronate sodium) Tablets, Merck & Co., Inc., Labeling Revision
  • Fosamax (alendronate sodium) Oral Solution, Merck & Co., Inc., Labeling Revision
  • Fosamax Plus D (alendronate sodium and cholecalciferol) Tablets, Merck & Co., Inc., Labeling Revision
  • Norditropin (somatropin [rDNA origin]) Injection, Novo Nordisk Inc., Manufacturing Change or Addition
  • Tamsulosin Hydrochloride Capsules, IMPAX Laboratories, Inc., Approval
  • Temozolomide Capsules, Barr Laboratories, Inc., Approval

March 2, 2010

  • Articaine Hydrochloride and Epinephrine Injection, TechReg Services, Inc., Approval
  • Cefoxitin Injection, West-Ward Pharmaceutical Corp., Approval
  • Hydralazine Hydrochloride Tablets, Zydus Pharmaceuticals USA, Approval
  • Janumet (metformin hydrochloride and sitagliptin phosphate) Tablets, Merck, Efficacy Supplement with Clinical Data to Support
  • Januvia (sitagliptin phosphate) Tablets, Merck Co. Inc., Efficacy Supplement with Clinical Data to Support
  • Wellbutrin (bupropion hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision
  • Wellbutrin (bupropion hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision
  • Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets, Biovail Technologies, Ltd., Labeling Revision
  • Vpriv (velaglucerase alfa) Injection, Shire Human Genetic Therapies, Inc., Approval
  • Zyban (bupropion hydrochloride) Extended-Release Tablets, GlaxoSmithKline, Labeling Revision
  • Zyrtec Allergy (cetirizine hydrochloride) Tablets, McNeil Consumer Healthcare, Labeling Revision

March 1, 2010

February 25, 2010

  • Bystolic (nebivolol hydrochloride) Tablets, Forest Laboratories, Inc., Efficacy Supplement
  • Cayston (aztreonam) Inhalation Solution, Gilead Sciences, Inc., Approval
  • Cefoxitin and Dextrose in Duplex Container Injection, B. Braun Medical, Inc., Labeling Revision
  • Cyanokit (hydroxocobalamin) Injection, Merck Sante s.a.s., Labeling Revision
  • Dyazide (hydrochlorothiazide and triamterene) Capsules, GlaxoSmithKline, Labeling Revision
  • Finasteride Tablets, Accord Healthcare, Inc., Approval 
  • Forane (isoflurane) Inhalation Liquid, Baxter Healthcare Corporation, Labeling Revision
  • Imiquimod Cream, Nycomed, Inc., Approval
  • Intelence (etravirine) Tablets, Tibotec, Inc., Labeling Revision
  • Marcaine (bupivacaine hydrochloride) Injection, Hospira, Inc., Labeling Revision
  • Marcaine (bupivacaine hydrochloride) Injection, Hospira, Inc., Labeling Revision
  • Naratriptan Tablets, Roxane Laboratories, Inc., Tentative Approval
  • Niaspan (niacin) Extended-Release Tablets, Abbott Laboratories, Labeling Revision
  • Norethindrone and Ethinyl Estradiol Tablets, Watson Laboratories, Inc., Approval
  • Polyethylene Glycol 3350 and Electrolytes Oral Solution, Paddock Laboratories, Approval
  • Rocaltrol (calcitriol) Capsules, Validus Pharmaceuticals, Labeling Revision
  • Septocaine (articaine hydrochloride and epinephrine) Injection, Deproco, Inc., Labeling Revision
  • Tamiflu (oseltamivir phosphate) Capsules, Hoffmann-La Roche, Inc., Labeling Revision and Efficacy Supplement
  • Tamiflu (oseltamivir phosphate) Oral Suspension, Hoffmann-La Roche, Inc., Labeling Revision and Efficacy Supplement
  • Tracleer (bosentan) Tablets, Actelion, Ltd., Labeling

February 24, 2010

  • Carbocaine (mepivacaine hydrochloride) Injection, Hospira, Inc., Labeling Revision
  • Desloratadine Tablets, Orchid Healthcare, Approval
  • Mirapex ER (pramipexole dihydrochloride) Extended-Release Tablets, Boehringer Ingelheim Pharmaceuticals, Inc., Approval
  • Naropin (ropivacaine hydrochloride monohydrate) Injection, APP Pharmaceuticals, Labeling Revision
  • Nesacaine (chloroprocaine hydrochloride) Injection, APP Pharmaceuticals, Labeling Revision 
  • Xylocaine (lidocaine hydrochloride) Injection, APP Pharmaceuticals, Labeling Revision
  • Xylocaine 4% Preservative Free (lidocaine hydrochloride) Injection, APP Pharmaceuticals, Labeling Revision

February 23, 2010

  • Alendronate Sodium Tablets, Cadista Pharmaceuticals Inc., Approval
  • Baclofen Tablets, Matrix Laboratories Ltd., Approval
  • Caduet (amlodipine besylate and atorvastatin calcium) Tablets, Pfizer, Inc., Labeling Revision 
  • Ciclopirox Topical Solution, VersaPharm Inc., Approval
  • Coartem (artemether and lumefantrine) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
  • Donepezil Hydrochloride Tablets, Torrent Pharmaceuticals Ltd., Tentative Approval
  • Metformin Hydrochloride Extended-Release Tablets, Torrent Pharmaceuticals Ltd., Approval 
    

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