New and Generic Drug Approvals

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

November 20, 2009

• Acetaminophen Extended-Release Tablets, Ranbaxy Laboratories, Ltd., Approval
• Actoplus Met (pioglitazone hydrochloride and metformin hydrochloride) Tablets, Takeda Global Research & Development Center, Inc., Labeling Revision
• Calcipotriene Topical Solution, Hi-Tech Pharmacal Co., Inc., Approval
• Ciprofloxacin in Dextrose 5% in Plastic Container Injection, West-Ward Pharmaceutical Corp., Approval
• Cordarone (amiodarone hydrochloride) Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision
• Dorzolamide Hydrochloride Ophthalmic Solution, PharmaForce, Inc., Approval
• Dorzolamide Hydrochloride and Timolol Mealeate Ophthalmic Solution, Alcon Research, Ltd., Approval
• Geodon (ziprasidone hydrochloride) Capsules, Pfizer, Inc., Efficacy Supplement with Clinical Data to Support
• Lamisil AT (terbinafine hydrochloride) Topical Cream, Novartis Consumer Health, Labeling Revision
• Nizatidine Oral Solution, Amneal Pharmaceuticals, Approval
• Revatio (sildenafil) Injection, Pfizer, Inc., Approval 
• Vimpat (lacosamide) Tablets, Schwarz Biosciences, Inc., Labeling Revision
• Vimpat (lacosamide) Injection, Schwarz Biosciences, Inc., Labeling Revision 

November 19, 2009

• Adenocard (adenosine) Injection, Astellas Pharma US, Inc., Labeling Revision
• Methocarbamol Tablets, Hetero Drugs Ltd. Unit III, Approval 
• Nicardipine Hydrochloride Injection, PharmaForce, Inc., Approval
• Nicardipine Hydrochloride Injection, GeneraMedix, Inc., Approval
• Nicardipine Hydrochloride Injection, Navinta, LLC., Approval
• Nicardipine Hydrochloride Injection, Sun Pharma Global Inc., Approval
• Nicardipine Hydrochloride Injection, Wockhardt Limited, Approval
• Norethindrone Acetate and Ethinyl Estradiol Tablets, Barr Laboratories, Inc., Approval
• RETROVIR (zidovudine) Capsules, GlaxoSmithKline, Labeling Revision
• RETROVIR (zidovudine) Syrup, GlaxoSmithKline, Efficacy Supp. w/Clinical Data
• Truvada (emtricitabine and tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Labeling Revision
• Zestril (lisinopril) Tablets, AstraZeneca Pharmaceuticals, Labeling Revision
• Zestoretic (lisinopril and hydrochlorothiazide) Tablets, AstraZeneca Pharmaceuticals, Labeling Revision
• Ziac (bisoprolol fumarate and hydrochlorothiazide) Tablets, Duramed Pharmaceuticals, Inc., Labeling Revision

November 18, 2009

• Adenosine Injection, Akorn Inc., Tentative Approval 
• Betaxolol Ophthalmic Solution, Wockhardt Ltd., Approval
• Butalbital, Acetaminophen and Caffeine Capsule, NexGen Pharmaceuticals, Approval 
• Famotidine Tablets, Ranbaxy Laboratories Ltd., Approval
• Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, Dr. Reddy's Laboratories Ltd., Tentative Approval 
• Lysteda (tranexamic acid) Tablets,  Xanodyne Pharmaceuticals, Inc., Approval
• Qutenza (capsaicin) Patch, Neurogesx, Inc., Approval
• Rilutek (riluzole) Tablets, Sanofi Aventis U.S., L.L.C., Labeling Revision
• Soma Compound (aspirin and carisoprodol) Tablets, Meda Pharmaceuticals, Inc., Labeling Revision
• Soma (carisoprodol) Tablets, Meda Pharmaceuticals, Inc., Labeling Revision

November 16, 2009

• Eovist (gadoxetate disodium) Injection, Bayer HealthCare Pharmaceuticals, Manufacturing Change or Addition
• Imatinib Mesylate Tablets, Sun Pharmaceutical Industries Ltd., Tentative Approval 
• Nucynta (tapentadol hydrochloride) Tablets, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Labeling Revision
• REBETOL (ribavirin) Oral Solution, Schering Corporation, Labeling Revision
• Rheumatrex (methotrexate sodium) Tablets, Dava Pharmaceuticals, Inc., Manufacturing Change or Addition
• Tramadol Hydrochloride Extended-Release Tablets, Par Pharmaceutical, Inc., Approval
• Ultravist (iopromide) Injection, Bayer HealthCare Pharmaceuticals, Manufacturing Change or Addition
• Ultravist (iopromide) Injection Pharmacy Bulk Packaging, Bayer HealthCare Pharmaceuticals, Manufacturing Change or Addition

November 13, 2009

• Actiq (fentanyl citrate) Lozenges, Cephalon, Labeling Revision
• Azithromycin Injection, Generamedix, Approval
• Benzonatate Capsules, Mikart, Approval
• Catapres (clonidine hydrochloride) Tablets, Boehringer Ingelheim, Labeling Revision
• Catapres TTS (clonidine) Film, Boehringer Ingelheim, Labeling Revision
• Ciclopirox Topical Cream, Glenmark Pharmaceuticals, Approval
• Cetirizine hydrochloride Syrup, Sun Pharmaceutical Industries, Approval
• Effexor (venlafaxine hydrochloride) Tablets, Wyeth Pharmaceuticals, Labeling Revision
• Geodon (ziprasidone hydrochloride) Capsules, Pfizer, Labeling Revision
• Helidac bismuth subsalicylate; metronidazole; tetracyline hydrochloride Chewable Tablets & Capsules, Prometheus Laboratories, Labeling Revision
• Irinotecan hydrochloride Injection, Ebewe Pharmaceutical, Approval
• Lansoprazole Delayed-Release Capsules, Teva Pharmaceuticals, Approval
• Lotensin (benazepril/hydrochlorothiazide) Tablets, Novartis, Labeling Revision
• Perindopril erbumine Tablets, Aurobindo Pharmaceutical, Approval
• Perindopril erbumine Tablets, Ivax Pharmaceuticals, Approval
• Perindopril erbumine Tablets, Roxane, Approval
• Plavix (clopidogrel bisulfate) Tablets, Sanofi Aventis, Labeling Revision
• Pristiq (desvenlafaxine succinate) Tablets, Wyeth Pharmaceuticals, Labeling Revision
• Protonix (pantoprazole sodium) Delayed-Release Oral Suspension, Wyeth Pharmaceuticals, Labeling Revision
• Protonix (pantoprazole sodium) Delayed-Release Tablets, Wyeth Pharmaceuticals, Labeling Revision & Patient Population Altered
• Rebetol (ribavirin) Oral Solution, Schering, Labeling Revision
• Sensipar (cinacalcet hydrochloride) Tablets, Amgen, Labeling Revision
• Soma compound with codeine Tablets, Meda Pharmaceuticals, Labeling Revision
• Tapentadol hydrochloride Tablets, Ortho McNeil Janssen, Labeling Revision
• Tekturna (aliskiren hemifumarate) Tablets, Novartis, Labeling Revision
• Viread (tenofovir disoproxil fumarate) Tablets, Gilread, Labeling Revision
• Zometa (zoledronic acid) Infusion, Novartis, Labeling Revision

November 12, 2009

• Lotensin HCT (benazepril/hydrochlorothiazide) Tablets, Novartis, Labeling Revision
• Pennsaid (diclofenac sodium) Topical Solution, Nuvo Research, Approval