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Drugs
New and Generic Drug Approvals
Visit Drugs@FDA to search Drug Approval Reports by Month.
September 8, 2010
- Aciphex (rabeprazole sodium) Delayed-Release Tablets, Eisai Medical Research, Inc., Labeling Revision
- Cutivate (fluticasone propionate) Lotion, Nycomed US Inc., Labeling Revision
- Dexilant (dexlansoprazole) Delayed Release Capsules, Takeda Global Research & Development Center, Inc., Labeling Revision
- Magnesium Hydroxide, Omeprazole and Sodium Bicarbonate Tablets, Santarus, Inc., Labeling Revision
- Prilosec (omeprazole) Delayed-Release Capsules, AstraZeneca LP, Labeling Revision
- Prilosec (omeprazole magnesium) Delayed-Released Oral Solution, AstraZeneca LP, Labeling Revision
- Protonix (pantoprazole sodium) Delayed-Release Oral Solution, Pfizer, Labeling Revision
- Protonix (pantoprazole sodium) Delayed-Release Tablets, Pfizer, Labeling Revision
- Protonix I.V. (pantoprazole sodium) I.V. Injection, Pfizer, Labeling Revision
- Zegerid (omeprazole and sodium bicarbonate) Capsules, Santarus, Inc., Labeling Revision
- Zegerid (omeprazole and sodium bicarbonate) Oral Suspension, Santarus, Inc., Labeling Revision
- Zegerid (magnesium hydroxide, omeprazole and sodium bicarbonate) Chewable Tablets, Santarus, Inc., Labeling Revision
- Zyrtec Allergy (cetirizine hydrochloride) Orally Disintegrating Tablets, McNeil Consumer Healthcare, Approval
September 7, 2010
- Advil Cold & Sinus (ibuprofen and pseudoephedrine hydrochloride) Tablets, Wyeth Consumer Healthcare, Labeling Revision
- Apokyn (apomorphine hydrochloride) Subcutaneous Injection, Ipsen Ltd., Labeling Revision
- Children’s Advil (ibuprofen) Oral Suspension, Wyeth Consumer Healthcare, Labeling Revision
- Combunox (ibuprofen and oxycodone hydrochloride) Tablets, Forest Laboratories, Inc., Labeling Revision
- Cutivate (fluticasone propionate) Cream, Nycomed US Inc., Labeling Revision
- Lotronex (alosetron hydrochloride) Tablets, Prometheus Laboratories, Inc., Labeling Revision
- Platinol (cisplatin) Injection, Bristol-Myers Squibb Co., Labeling Revision
- Platinol-AQ (cisplatin) Injection, Bristol-Myers Squibb Co., Labeling Revision
September 3, 2010
- Advil PM (ibuprofen and diphenhydramine citrate) Tablets, Wyeth Consumer Healthcare, Labeling Revision
- Advil (ibuprofen) Tablets, Wyeth Consumer Healthcare, Labeling Revision
- Differin (adapalene) Gel, Galderma Laboratories, Labeling Revision
- Klonopin (clonazepam) Tablets, Hoffman-La Roche, Inc., Labeling Revision
- Klonopin (clonazepam) Orally Disintegrating Tablets, Hoffman-La Roche, Inc., Labeling Revision
- Topiramate Tablets, Wockhardt, Ltd., Approval
September 2, 2010
- Advil Allergy Sinus (ibuprofen, chlorpheniramine maleate, and pseudoephedrine hydrochloride) Tablets, Wyeth Consumer Healthcare, Labeling Revision
- Lumigan (bimatoprost) Ophthalmic Solution, Allergan, Inc., Approval
- Ozurdex (dexamethasone) Intravitreal Implant, Allergan, Inc., Labeling Revision
- Phendimetrazine Tartrate Tablets, KVK-TECH, Inc., Approval
- Travatan Z (travoprost) Ophthalmic Solution, Alcon Research, Ltd., Efficacy Supplement
- Travatan (travoprost) Ophthalmic Solution, Alcon Research, Ltd., Efficacy Supplement
- Xalatan (latanoprost) Ophthalmic Solution, Pharmacia and Upjohn Company, Labeling Revision
September 1, 2010
- Alphagan P (brimonidine tartrate) Ophthalmic Solution, Allergan, Inc., Labeling Revision
- Alphagan P (brimonidine tartrate) Ophthalmic Solution, Allergan, Inc., Labeling Revision
- Ansaid (flurbiprofen) Tablets, Pharmacia & Upjohn Company, Labeling Revision
- Carbinoxamine Maleate Tablets, Cypress Pharmaceutical, Inc., Approval
- Commit (nicotine polacrilex) Oral Lozenge, GlaxoSmithKline Consumer Healthcare, Labeling Revision
- Cubicin (daptomycin) I.V. Injection, Cubist Pharmaceuticals, Inc., Labeling Revision
- Exelon (rivastigmine) Transdermal System, Novartis Pharmaceuticals Corp., Labeling Revision
- Feldene (piroxicam) Capsules, Pfizer Inc., Labeling Revision
- Heparin Sodium and Dextrose in 5% Plastic Container Injection, Baxter Healthcare Corporation, Labeling Revision
- Heparin Sodium and Dextrose in 0.9% in Plastic Container Injection, Baxter Healthcare Corporation, Labeling Revision
- Taxol (paclitaxel) Injection, Bristol-Myers Squibb Company, Labeling Revision
- Tramadol Hydrochloride Orally Disintegrating Tablets, Victory Pharma, Inc., Labeling Revision
August 31, 2010
- Atomoxetine Hydrochloride Capsules, Actavis Elizabeth LLC, Approval
- Atomoxetine Hydrochloride Capsules, Mylan Pharmaceuticals, Inc., Approval
- Atomoxetine Hydrochloride Capsules, Sun Pharmaceuticals, Industries, Inc., Approval
- Lamivudine, Nevirapine, and Stavudine Tablets, Macleods Pharmaceuticals Ltd., Tentative Approval
- Lupron Depot-Ped (leuprolide acetate) Injection, Abbott Laboratories, Labeling Revision
- Nandrolone Decanoate Injection, PharmaForce, Inc., Approval
- Perindopril Erbumine Tablets, Apotex Corp., Approval
- Risperdal (risperidone) Tablets, Johnson Pharmaceutical Research & Development, L.L.C., Labeling Revision
- Risperdal (risperidone) Oral Solution, Johnson Pharmaceutical Research & Development, L.L.C., Labeling Revision
- Risperdal Consta (risperidone) Intramuscular Injection, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Labeling Revision
- Risperdal (risperidone) Oral Disintegrating Tablets, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Labeling Revision
- Saphris (asenapine maleate) Tablets, Organon USA Inc., Efficacy Supplement with Clinical Data to Support
- Simvastatin Tablets, Actavis Totowa LLC, Approval
- Suboxone (buprenorphine and naloxone) Film Oral, Reckitt Benckiser Pharmaceuticals Inc., Approval
- Valsartan and Hydrochlorothiazide Tablets, Mylan Pharmaceuticals Inc., Tentative Approval
August 27, 2010
- Letairis (ambrisentan) Tablets, Gilead Sciences, Inc., Supplement
- Omnitrope (somatropin [rDNA origin]) Injection, Sandoz, Inc., Efficacy Supplement with Clinical Data to Support
- Tekamlo (aliskiren and amlodipine) Tablets, Novartis Pharmaceuticals Corp., Approval
August 25, 2010
- Cayston (aztreonam) Inhalation Solution, Gilead Sciences, Inc., Labeling Revision
- Children's Advil Cold (ibuprofen and pseudoephedrine) Oral Suspension, Wyeth Consumer Healthcare, Labeling Revision
- Clonidine Patch, Barr Laboratories, Inc., Approval
- Duloxetine Hydrochloride Delayed-Release Capsules, Zydus Healthcare, Tentative Approval
- Fanapt (iloperidone) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Hydrocortisone Topical Cream, Lyne Laboratories, Inc., Approval
- Paricalcitol Capsules, TEVA Pharmaceuticals, Tentative Approval
- Zoledronic Acid Injection, Pharmaceutics International Inc., Tentative Approval
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