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Drugs
New and Generic Drug Approvals
Visit Drugs@FDA to search Drug Approval Reports by Month.
February 4, 2010
- Accutane (isotretinoin) Capsules, Hoffmann-La Roche Inc., Labeling Revision
- Cancidas (caspofungin acetate) I.V. Injection, Merck Research Laboratories, Labeling Revision
- Exjade (deferasirox) Oral Suspension Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Kaletra (lopinavir and ritonavir) Tablets, Abbott Laboratories, Labeling Revision
- Kaletra (lopinavir and ritonavir) Oral Solution, Abbott Laboratories, Labeling Revision
- Kenalog-10 (triamcinolone acetonide) Injection, Apothecon Inc., Labeling Revision
- Kenalog-40 (triamcinolone acetonide) Injection, Apothecon Inc., Labeling Revision
- Oleptro (trazodone hydrochloride) Extended-Release Tablets, Labopharm Canada, Approval
- Olopatadine Hydrochloride Ophthalmic Solution, Sandoz Inc., Tentative Approval
- PEG 3350 and Electrolytes (polyethylene glycol 3350, potassium chloride, sodium bicarbonate, sodium chloride and sodium sulfate anhydrous) Oral Solution, Mylan Pharmaceuticals Inc., Approval
- Pexeva (paroxetine mesylate) Tablets, Noven Therapeutics, LLC, Labeling Revision
- Prezista (darunavir ethanolate) Tablets, Tibotec Inc., Efficacy Supplement
February 2, 2010
- Cefotaxime Sodium Injection, Cephazone Pharma LLC, Approval
- Granisetron Hydrochloride Injection, West-Ward Pharmaceutical Corp., Approval
- Lorazepam Oral Concentrate, Amneal Pharmaceuticals, Approval
- Orfadin (nitisinone) Capsules, R & R Registrations, Labeling Revision
- Sandostatin (octreotide acetate) Injection, Novartis Pharmaceuticals Corp., Labeling Revision
- Sandostatin LAR (octreotide acetate) Injection, Novartis Pharmaceuticals Corp., Labeling Revision
- Zoledronic Acid Injection, Hospira, Inc., Tentative Approval
January 28, 2010
- Demadex (torsemide) Tablets, Meda Pharmaceuticals, Labeling Revision
- Oxcarbazepine Tablets, Cadista Pharmaceuticals, Inc., Approval
- Perindopril Erbumine Tablets, Lupin Limited, Approval
- Rapamune (sirolimus) Oral Solution, Wyeth Pharmaceuticals, Inc., Labeling Revision
- Rapamune (sirolimus) Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision
- Symbyax (olanzapine and fluoxetine hydrochloride) Capsules, Eli Lilly and Company, Labeling Revision
- Zyprexa (olanzapine) Intramuscular Injection, Eli Lilly and Company, Labeling Revision
- Zyprexa (olanzapine) Tablets, Eli Lilly and Company, Labeling Revision
- Zyprexa Zydis (olanzapine) Orally Disintegrating Tablets, Eli Lilly and Company, Labeling Revision
January 27, 2010
- Morphine Sulfate Oral Solution, Roxane Laboratories, Inc., Efficacy
- Videx (didanosine) Oral Solution, Bristol-Myers Squibb Co., Supplement
- Videx EC (didanosine) Delayed-Release Capsules, Bristol-Myers Squibb Co. Supplement
- Zoledronic Acid Injection, Hospira, Inc., Tentative Approval
January 26, 2010
- Victoza (liraglutide) Subcutaneous Solution, Novo Nordisk, Inc., Approval
January 25, 2010
- AMPYRA (dalfampridine) Extended-Release Tablets, Acorda Therapeutics, Inc., Approval
- Bumex (bumetanide) Tablets, Validus Pharmaceuticals, Labeling Revision
- Coumadin (warfarin sodium) Tablets, Bristol-Myers Squibb Co., Labeling Revision
- Crestor (rosuvastatin calcium) Tablets, IPR Pharmaceuticals, Inc., Labeling Revision
- Ethrane (enflurane) Inhalation Liquid, Baxter Healthcare Corp., Labeling Revision
- Lusedra (fospropofol disodium) I.V. Solution, Eisai Inc., Labeling Revision
- Mephyton (Phytonadione) Tablets, Aton Pharma, Inc., Labeling Revision
- Milrinone Lactate in Plastic Containers Injection, Hikma Farmaceutica, Approval
- Qualaquin (quinine sulfate) Capsules, AR Holding Company, Inc., Labeling Revision
- Reyataz (atazanavir sulfate) Capsules, Bristol-Myers Squibb Co., Labeling Revision
- Trandolapril and Verapamil Hydrochloride Extended-Release Tablets, Glenmark Generics, Tentative Approval
- Ultane (sevoflurane) Liquid Inhalation, Abbott Laboratories, Labeling Revision
January 22, 2010
- Ampicillin Sodium Injection, ACIC Fine Chemicals, Inc., Approval
- Finasteride Tablets, Zydus Pharmaceuticals, Approval
- Fluvastatin Capsules, Mylan Pharmaceuticals, Inc., Tentative Approval
- Gemcitabine Injection, Actavis Totowa, LLC, Tentative Approval
- Ibandronate Sodium Tablets, Mylan Pharmaceuticals, Inc., Tentative Approval
- Lamivudine and Zidovudine Tablets, TEVA Pharmaceuticals, Tentative Approval
- Latanoprost Ophthalmic Solution, Apotex, Inc., Tentative Approval
- Nicardipine Hydrochloride Injection, Bedford Laboratories, Approval
January 21, 2010
- Amlodipine and Valsartan Tablets, Matrix Laboratories Ltd., Tentative Approval
- Cefuroxime Sodium, Injection, Samson Medical Technologies, Approval
- Ergocalciferol Capsules, Sun Pharmaceutical Industries, Inc., Approval
- Gabapentin Capsules, InvaGen Pharmaceuticals, Approval
- Metformin Hydrochloride Extended-Release Tablets, Torrent Pharmaceuticals Ltd., Approval
- Miconazole Nitrate Vaginal Cream, Perrigo R&D Company, Approval
- Oxaliplatin Injection, Actavis Totowa, Tentative Approval
- Promethazine Hydrochloride Syrup, Amneal Pharmaceuticals, Approval
- Solodyn (minocycline hydrochloride) Extended-Release Tablets, Medicis Pharmaceutical Corporation, Labeling Revision
January 20, 2010
- Amlodipine Besylate and Benazepril Hydrochloride Capsules, Cobalt Laboratories Inc., Tentative Approval
- Aristocort (triamcinolone diacetate) Injection, Sandoz Inc., Labeling Revision
- Cardura (doxazosin mesylate) Tablets, Pfizer, Inc., Labeling Revision
- Cefuroxime Sodium in Plastic Container (cefuroxime sodium) Injection, Samson Medical Technologies, Approval
- Clozaril (clozapine) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Estradiol Valerate Injection, PharmaForce, Inc., Approval
- Gemcitabine Injection, Pliva Lachema, Tentative Approval
- Hydrochlorothiazide Capsules, Unichem Laboratories Ltd., Approval
- Indocin (indomethacin sodium) Injection, Lundbeck Inc., Labeling Revision
- Memantine Hydrochloride Tablets, Lupin Ltd., Tentative Approval
- Oxaliplatin Injection, Pliva Lachema, Approval
- Toprol-XL (metoprolol succinate) Extended-Release Tablets, AstraZeneca LP, Labeling Revision
January 14, 2009
- Cardene (nicardipine hydrochloride) Injection, EKR Therapeutics, Inc., Labeling Revision
- Uniretic (moexipril hydrochloride and hydrochlorothiazide) Tablets, Schwarz Pharma, Labeling Revision
- Viramune (nevirapine) Oral Suspension, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision
- Viramune (nevirapine) Tablets, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision
January 13, 2009
- Ibutilide Fumarate Injection, GeneraMedix Inc., Approval
- Ibutilide Fumarate Injection, PharmaForce, Inc., Approval
- Ibutilide Fumarate Injection, Bioniche Pharma, Approval
- Levofloxacin Tablets, Wockhardt Ltd., Tentative Approval
- Vasovist (gadofosveset trisodium) Injection, Lantheus Medical Imaging, Labeling Revision
- Viagra (sildenafil citrate) Tablets, Pfizer, Inc., Labeling Revision
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