New and Generic Drug Approvals
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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

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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