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New and Generic Drug Approvals

Posted Jun 24 2010 11:40am

Visit Drugs@FDA to search Drug Approval Reports by Month. 

June 24,  2010

  • Aztreonam Injection, APP Pharmaceuticals, LLC, Approval
  • Dexilant (dexlansoprazole) Delayed-Release Capsules, Takeda Pharmaceuticals, Labeling Revision
  • Dulera (mometasone furoate and formoterol fumarate) Inhalation Aerosol, Schering Corp., Approval
  • Isopto Carpine (pilocarpine hydrochloride) Ophthalmic Solution, Alcon Research Ltd., Approval
  • Scanlux-300 and Scanlux-370 (Iopamidol) Injection, Sanochemia Corp., Approval 
  • Ulesfia (benzyl alcohol) Lotion, Shionogi Pharma, Inc., Approval
  • VFEND (voriconazole) Tablets, Pfizer, Inc., Labeling Revision
  • VFEND I.V. (voriconazole) I.V. Injection, Pfizer, Inc., Labeling Revision
  • VFEND (voriconazole) Oral Suspension, Pfizer, Inc., Labeling Revision

June 23,  2010

  • Alprazolam Tablets, Sun Pharma Global, Inc., Approval
  • Articaine Hydrochloride 4% and Epinephrine 1:100,000 Injection, Hospira Inc., Approval
  • Clindamycin Phosphate Topical Solution, VersaPharm Inc., Approval
  • COSOPT (dorzolamide hydrochloride and timolol maleate) Ophthalmic Solution, Merck & Co, Inc., Labeling Revision
  • Pemetrexed Injection, APP Pharmaceuticals, LLC, Tentative Approval
  • TRUSOPT (dorzolamide hydrochloride) Ophthalmic Solution, Merck & Co, Inc., Labeling Revision

June 22, 2010

  • Azelastine Hydrochloride Ophthalmic Solution, Sun Pharmaceutical Industries, Inc., Approval
  • Ganciclovir Injection, APP Pharmaceuticals, LLC, Approval
  • Namenda XR (memantine hydrochloride) Extended Release Capsules, Forest Laboratories, Inc., Approval
  • Nedocromil Sodium Ophthalmic Solution, Akorn, Inc., Tentative Approval
  • Nifedipine Extended-Release Tablets, Mylan Pharmaceuticals, Inc., LLC, Approval

June 18,  2010

  • Benzaclin (benzoyl peroxide and clindamycin phosphate) Topical Gel, sanofi-aventis U.S., LLC, Labeling Revision
  • Epinastine Hydrochloride Ophthalmic Solution, PharmaForce, Inc., Tentative Approval
  • Jevtana (cabazitaxel) Injection, sanofi-aventis U.S., Inc., Approval
  • Levetiracetam Injection, Sun Pharmaceutical Industries, Ltd., Approval
  • Staxyn (vardenafil hydrochloride) Orally Disintegrating Tablets, Bayer Healthcare Pharmaceuticals, Approval

June 17,  2010

  • Avodart (dutasteride) Capsules, GlaxoSmithKline, Labeling Revision
  • Cetirizine Hydrochloride Tablets, Cadista Pharmaceuticals Inc., Approval
  • Epinastine Hydrochloride Ophthalmic Solution, PharmaForce, Inc., Tentative Approval
  • Lorazepam Oral Concentrate, Pharmaceutical Associates, Inc., Approval
  • Qualaquin (quinine sulfate) Capsules, AR Holding Company, Inc., Labeling Revision

June 16,  2010

  • Cafcit (caffeine citrate) Injection and Oral Solution, Bedford Laboratories, Labeling Revision
  • Heparin Sodium Injection, APP Pharmaceuticals, LLC, Labeling Revision
  • Humulin R (insulin [rDNA origin]) Injection, Eli Lilly and Co., Labeling Revision
  • Humulin N NPH (insulin susp isophane [rDNA origin] ) Injection, Eli Lilly and Co., Labeling Revision
  • Humulin Mix 70/30 (insulin recombinant human and insulin susp isophane recombinant human ) Injection, Eli Lilly and Co., Labeling Revision
  • Mycophenolate Mofetil Tablets, Strides Inc., Approval
  • Novantrone (mitoxantrone hydrochloride) Injection, EMD Serono, Labeling Revision

June 15, 2010

  • Jalyn (dutasteride and tamsulosin hydrochloride) Capsules, GlaxoSmithKline LLC, Approval
  • Kaletra (lopinavir and ritonavir) Oral Solution, Abbott Laboratories, Labeling Revision
  • Kaletra (lopinavir and ritonavir) Tablets, Abbott Laboratories, Labeling Revision
  • Mozobil (plerixafor) Injection, Genzyme Corp., Labeling Revision

June 14,  2010

June 10,  2010

June 9, 2010

  • Cefuroxime Axetil Tablets, Alkem Laboratories Ltd., Approval
  • Clenz-Lyte (polyethylene glycol 3350, potassium chloride, sodium bicarbonate, sodium chloride and sodium sulfate) Oral Solution , Paddock Laboratories, Inc., Approval
  • Donepezil Hydrochloride Orally Disintegrating Tablets, Zydus Pharmaceuticals USA Inc., Tentative Approval
  • Donepezil Hydrochloride Tablets, Hikma Pharmaceuticals, Tentative Approval
  • Finasteride Tablets, Hetero Drugs Ltd., Unit III, Approval
  • Finasteride Tablets, Hetero Drugs Ltd., Unit III, Tentative Approval
  • Hydroxyzine Hydrochloride Tablets, Mylan Pharmaceuticals, Inc., Approval

June 8,  2010

  • Adapalene Gel, Pliva Hrvatska d.o.o., Approval
  • Brovana (arformoterol tartrate) Inhalation Solution, Sepracor, Inc., Labeling Revision
  • Ceftazidime Injection, Aurobindo Pharma Ltd., Approval
  • Chlorzoxazone Tablets, Mikart, Inc., Approval
  • Clinoril (sulindac) Tablets, Merek & Co., Inc., Labeling Revision
  • Cysview (hexaminolevulinate hydrochloride) Intravesical Solution, Photocure ASA, Approval
  • Gabapentin Tablets, Matrix Laboratories Ltd., Approval
  • Lamotrigine Tablets, Lupin Ltd., Approval
  • Livalo (pitavastatin calcium) Tablets, Kowa Co. Ltd., Labeling Revision
  • Miconazole Nitrate Vaginal Cream, Perrigo R&D Co., Approval
  • Nimbex (cisatracurium besylate) Injection, Abbott Laboratories, Labeling Revision
  • Ovidrel  (choriogonadotropin alfa) Injection, EMD Serono, Inc., Labeling Revision
  • Oxaliplatin Injection, APP Pharmaceuticals, Approval
  • PrandiMet (metformin hydrochloride and repaglinide) Tablet, Novo Nordisk Inc., Labeling Revision
  • Taxotere (docetaxel) Injection Concentrate, sanofi-aventis U.S. LLC, Labeling Revision
  • Zafirlukast Tablets, Dr. Reddy's Laboratories Ltd., Tentative Approval
  • Zylet (loteprednol etabonate and tobramycin) Ophthalmic Suspension, Bausch & Lomb, Inc., Labeling Revision
    
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