LIST OF NEW AND GENERIC DRUGS APPROVED BY FDA

CLICK ON THE THE DRUG  NAMES TO KNOW MORE DETAILS ABOUT EACH DRUG


December 2, 2010

·         Abilify (aripiprazole) Intramuscular Injection, Otsuka Pharmaceutical Development & Commercialization, Inc., Labeling Revision

·         Abilify (aripiprazole) Orally Disintegrating Tablet, Otsuka Pharmaceutical Development & Commercialization, Inc., Labeling Revision 

·         Abilify (aripiprazole) Oral Solution, Otsuka Pharmaceutical Development & Commercialization, Inc., Labeling Revision 

·         Abilify (aripiprazole) Tablets, Otsuka Pharmaceutical Development & Commercialization, Inc., Labeling Revision  

·         Ciprofloxacin Extended Release (ciprofloxin and ciprofloxin hydrochloride) Extended-Release Tablets, Watson Laboratories, Inc., Approval 

·         Cubicin (daptomycin) I.V. Injection, Cubist Pharmaceuticals, Inc., Labeling Revision 

·         Hydrochlorothiazide Capsules, Alembic Ltd., Approval 

·         Indomethacin Extended-Release Capsules, Paddock Laboratories, Inc., Approval

·         Midazolam Hydrochloride Injection, Sagent Strides LLC, Approval 

·         Pramipexole Dihydrochloride Tablets, Actavis Pharma Manufacturing, Approval 

·         Prevacid 24HR (lansoprazole) Delayed-Release Capsules, Novartis Consumer Health, Inc., Labeling Revision 

·         Retisert (fluocinolone acetonide) Intravitreal Implant, Bausch & Lomb, Inc., Manufacturing Supplement 

·         Topotecan Hydrochloride Injection, Fresenius Kabi Oncology, Approval  

·         Topotecan Hydrochloride Injection, APP Pharmaceuticals, LLC, Approval 

December 1, 2010

·         Abacavir Sulfate Tablets, Matrix Laboratories, Ltd., Tentative Approval

·         Aricept (donepezil hydrochloride ) Tablets, Eisai, Inc., Labeling Revision

·         Concerta (methylphenidated hydrochloride) Extended-Release Tablets, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision

·         Donepezil Hydrochloride Tablets, Sun Pharmaceutical Industries, Ltd., Tentative Approval

·         Epinastine Hydrochloride Ophthalmic Solution, Apotex, Inc., Tentative Approval

·         Feraheme (ferumoxytol) Injection, AMAG Pharmaceuticals, Inc., Labeling Revision

·         Glucovance (glyburide and metformin hydrochloride) Tablets, Bristol-Myers Squibb Company, Labeling Revision

·         Levocetirizine Dihydrochloride Tablets, Synthon Pharmaceuticals, Inc., Approval

·         Pavulon (pancuronium bromide) Injection, Schering-Plough Corporation, Labeling Revision

·         Sustiva (efavirenz) Capsules, Bristol Myers Squibb, Labeling Revision

·         Sustiva (efavirenz) Tablets, Bristol Myers Squibb, Labeling Revision

November 29, 2010

·         Anectine (succinylcholine chloride) Injection, Sandoz Inc., Labeling Revision

·         Arduan (pipecuronium bromide) Injection, Schering-Plough Corp., Labeling Revision 

·         Axiron (testosterone) Topical Solution, Acrux Pharma Pty Ltd., Approval 

·         Cardizem (diltiazem hydrochloride) Tablets, Biovail, Labeling Revision

·         Cardizem CD (diltiazem hydrochloride) Extended-Release Capsules, Biovail, Labeling Revision

·         Cardizem LA (diltiazem hydrochloride) Extended-Release Tablets, Biovail, Labeling Revision

·         Ibuprofen and Diphenhydramine Capsule, Banner Pharmacaps, Inc., Approval

·         Mivacron (mivacurium chloride) Injection, Abbott Laboratories, Labeling Revision

·         Nimbex (cisatracurium besylate) Injection, Abbott Laboratories, Labeling Revision

·         Norcuron (vecuronium bromide) Injection, Schering-Plough Corp., Labeling Revision

·         Nuromax (doxacurium chloride) Injection, Abbott Laboratories, Labeling Revision

·         OxyContin (oxycodone hydrochloride) Extended-Release Tablets, Purdue Pharma L.P., Labeling Revision

·         Quelicin (succinylcholine chloride) Injection, Hospira, Inc., Labeling Revision

·         Rapamune (sirolimus) Oral Solution, Wyeth Pharmaceuticals, Inc., Labeling Revision

·         Rapamune (sirolimus) Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision 

·         Raplon (rapacuronium bromide) Injection, Schering-Plough Corp., Inc., Labeling Revision

·         Tiazac (diltiazem hydrochloride) Extended-Release Capsules, Biovail, Labeling Revision

·         Trandate (labetalol hydrochloride) Injection, Prometheus Laboratories, Inc., Labeling Revision

·         Trandate (labetalol hydrochloride) Tablets, Prometheus Laboratories, Inc., Labeling Revision

·         Zavesca (miglustat) Capsules, Actelion Pharmaceuticals Ltd., Labeling Revision

·         Zemuron (rocuronium bromide) Injection, Schering-Plough Corp., Labeling Revision

November 24, 2010

·         Buspar (buspirone hydrochloride) Tablets, Bristol-Myers Squibb, Labeling Revision

·         Crestor (rosuvastatin calcium) Tablets, IPR Pharmaceuticals, Inc., Approval

·         Duloxetine Hydrochloride Delayed-Release Capsules, Sun Pharma Global, Tentative Approval 

·         Gablofen (baclofen) Injection, CNS Therapeutics, Inc., Approval

·         Mefenamic Acid Capsules, Micro Labs Ltd., Approval 

·         Moxeza (moxifloxacin hydrochloride) Ophthalmic Solution, Alcon Research Ltd., Approval 

November 23, 2010

·         Duloxetine Hydrochloride Delayed-Release Capsules, Impax Laboratories, Inc., Tentative Approval

·         Eszopiclone Tablets, Mylan Pharmaceuticals Inc., Tentative Approval

·         OxyContin (oxycodone hydrochloride) Extended-Release Tablets, Purdue Pharma L.P., Labeling Revision

·         Reglan (metoclopramide hydrochloride) Tablet, Baxter Healthcare Corp., Labeling Revision

·         Reglan ODT (metoclopramide hydrochloride) Orally Disintegrating Tablets, Alaven Pharmaceutical, Labeling Revision

· Reglan (metoclopramide) Orally Disintegrating Tablet, Alaven Pharmaceutical, Labeling  Revision

· Revatio (sildenafil citrate) Tablets, Pfizer, Inc., Labeling Revision

· Revatio (sildenafil citrate) I.V. Solution, Pfizer, Inc., Labeling Revision

·         Serevent (salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, Labeling Revision

Zafirlukast Tablets, Dr. Reddy's Laboratories Ltd., Approval