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

• Copegus (ribavirin) Tablets, Hoffmann-La Roche, Inc., Labeling Revision
• Dilacor XR (diltiazem hydrochloride) Extended-Release Capsules, Watson Laboratories, Labeling Revision
• Hydrocodone Bitartrate and Acetaminophen Tablets, Mikart, Inc., Approval
• Oxaliplatin I.V. Injection, Fresenius Kabi Oncology Plc., Approval
• Peganone (ethotoin) Tablets, Lunbeck Pharmaceuticals, Inc., Labeling Revision
• Pramipexole Dihydrochloride Tablets, Zydus Pharmaceuticals, Tentative Approval
• Rosuvastatin Calcium Tablets, Watson Laboratories, Inc., Tentative Approval
• Sumatriptan Succinate Subcutaneous Injection, Sagent Strides LLC, Approval
• Tranxene T-Tab (clorazepate dipotassium) Tablets, Lunbeck Pharmaceuticals, Inc., Labeling Revision
• Zemplar (paricalcitol) Capsules, Abbott Laboratories, Labeling Revision

June 10,  2010

• Carbidopa and Levodopa Orally Disintegrating Tablets, Impax Laboratories, Inc., Approval
• Clinoril (sulindac) Tablets, Merck & Co., Inc., Labeling Revision
• Folic Acid Tablets, Vintage Pharmaceuticals, LLC, Approval
• Meclizine Hydrochloride Tablets, Cadista Pharmaceuticals, Inc., Approval
• Fosphenytoin Sodium Injection, Strides Arcolab, Ltd., Approval
• Risperidone Orally Disintegrating Tablets, Ratiopharm, Approval
• Simvastatin Tablets, Matrix Laboratories, Ltd., Approval
• Sulfamethoxazole and Trimethoprim Oral Suspension, Aurobindo Pharma, Ltd., Approval
• Terbinafine Hydrochloride Tablets, Breckenridge Pharmaceutical, Inc., Approval

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