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Drugs
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
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