• Epoprostenol Sodium Injection, Actelion, Ltd., Labeling Revision
• 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

August 20, 2010

• Atazanavir Sulfate Capsules, Emcure Pharmaceuticals, Ltd., Tentative Approval
• Flagyl (metronidazole) Tablets, Pfizer, Inc., Labeling Revision
• Flagyl (metronidazole) Capsules, Pfizer, Inc., Labeling Revision
• Flagyl ER (metronidazole) Extended-Release Tablets, Pfizer, Inc., Labeling Revision
• Losartan Potassium and Hydrochlorothiazide Tablets, Sandoz, Inc., Approval

August 19, 2010

• Duloxetine Hydrochloride Delayed-Release Capsules, Torrent Pharmaceuticals Ltd., Tentative Approval
• Fludeoxyglucose F-18 Injection, Feinstein Institute for Medical Research, Labeling Revision
• Venlafaxine Hydrochloride Extended-Release Tablets, Sun Pharmaceutical Industries, Inc., Approval 

August 18, 2010

• Ampicillin for Injection, Aurobindo Pharma Limited, Approval
• Donepezil Hydrochloride Tablets, Pliva Hrvatska d.o.o., Tentative Approval
• Gemfibrozil Tablets, Hikma Pharmaceuticals, Approval
• Plavix (clopidogrel bisulfate) Tablets, Sanofi-aventis, Labeling Revision
• ProAir HFA (albuterol sulfate) Inhalation Aerosol, Teva Branded Pharmaceuticals, Labeling Revision

August 17, 2010

• Aptivus (tipranavir) Capsules, Boehringer Ingelheim Pharmaceuticals, Labeling Revision
• Aptivus (tipranavir) Oral Soultion, Boehringer Ingelheim Pharmaceuticals, Labeling Revision
• Biltricide (praziquantel) Tablets, Bayer HealthCare Pharmaceuticals Inc., Labeling Revision
• Gemfibrozil Tablets, Hikma Pharmaceuticals, Approval

August 13, 2010

• Aleve (naproxen sodium) Capsules, Banner Pharmacaps, Inc., Labeling Revision
• Amerge (naratriptan hydrochloride) Tablets, GlazoSmithKline, Approval
• Creon (pancrelipase) Delayed-Release Capsules, Abbott Laboratories, Labeling Revision
• Imitrex (sumatriptan succinate) Tablets, GlaxoSmithKline, Labeling Revision
• Isosorbide Mononitrate Extended-Release Tablets, Vintage Pharmaceuticals, LLC, Approval
• Losartan Potassium Tablets, Apotex, Inc., Tentative Approval
• Maxalt (rizatriptan benzoate) Tablets, Merck Sharp & Dohme Corp., Labeling Revision
• Maxalt-MLT (rizatriptan benzoate) Orally Disintegrating Tablets, Merck Sharp & Dohme Corp., Labeling Revision
• Sumatriptan Succinate Subcutaneous Injection, Bedford Laboratories, Approval
• Zithromax (azithromycin) Oral Suspension, Pfizer Global Research and Development, Labeling Revision
• Zithromax (azithromycin) Tablets, Pfizer Global Research and Development, Labeling Revision
• Zithromax (azithromycin) Oral Suspension, Pfizer Global Research and Development, Labeling Revision
• Zithromax (azithromycin) Tablets, Pfizer Global Research and Development, Labeling Revision
• Zithromax (azithromycin) Tablets, Pfizer Global Research and Development, Labeling Revision
• Zithromax (azithromycin) Injection, Pfizer Global Research and Development, Labeling Revision
• Zomig-ZMT (zolmitriptan) Orally Disintegrating Tablets, AstraZeneca Pharmaceuticals, Approval
• Zomig (zolmitriptan) Tablets, AstraZeneca Pharmaceuticals, Labeling Revision 

August 12, 2010

• Actoplus Met (pioglitazone hydrochloride plus metformin hydrochloride) Tablets, Takeda Pharmaceuticals, Labeling Revision
• Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Labeling Revision
• Losartan Potassium and Hydrochlorothiazide Tablets, Apotex, Inc., Approval
• Ranitidine Hydrochloride Syrup, Aurobindo Pharma, Approval
• Risperidone Orally Disintegrating Tablets, Ranbaxy Laboratories Limited, Approval
• Singulair (montelukast sodium) Tablets, Merck and Co., Inc., Labeling Revision

August 11, 2010

• Diflucan (fluconazole) Tablets, Pfizer, Inc., Labeling Revision
• Diflucan in Dextrose 5% in Plastic Container (fluconazole) Injection, Pfizer, Inc., Labeling Revision
• Diflucan (fluconazole) Oral Suspension, Pfizer, Inc., Labeling Revision
• Levetiracetam Tablets, Orchid Healthcare, Approval
• Meridia (sibutramine hydrochloride) Capsules, Abbott Laboratories, Labeling Revision
• Ondansetron Hydrochloride Injection, Lannett Holdings, Inc., Approval
• Suprep (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Suspension, Braintree Laboratories, Inc., Approval
• Tekturna (aliskiren hemifumarate) Tablets, Novartis Pharmaceuticals Corporation, Labeling Revision
• Valcyte (valganciclovir hydrochloride) Tablets, Hoffmann-La Roche Inc., Efficacy Supplement and Labeling Revision
• Valturna (aliskiren hemifumarate and valsartan)  Tablets, Novartis Pharmaceuticals, Labeling Revision
• Venlafaxine Hydrochloride Tablets, Vintage Pharmaceuticals, Approval

August 10, 2010

• Letrozole Tablets, Synthon Pharmaceuticals, Inc., Tentative Approval
• Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision

August 9, 2010

• Altavera (levonorgestrel and ethinyl estradiol) Tablets, Sandoz Inc., Approval
• Brimonidine Tartrate Ophthalmic Solution, Alcon Research, Ltd., Labeling Revision
• Clotrimazole  Topical Cream, Glenmark Generics Inc., Approval
• Famotidine Tablets, Wockhardt Ltd., Approval
• Epzicom (abacavir sulfate and lamivudine) Tablets, ViiV Healthcare Company, Supplement
• Trizivir (abacavir sulfate, lamivudine, and zidovudine) Tablets, ViiV Healthcare Company, Supplement
• Ziagen (abacavir sulfate) Oral Solution, ViiV Healthcare Company, Supplement
• Ziagen (abacavir sulfate) Tablets, ViiV Healthcare Company, Supplement

August 5, 2010

• Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, Alcon Research, Ltd., Tentative Approval
• Ergocalciferol Capsules, Strides Arcolab, Approval
• Revlimid (lenalidomide) Capsules, Celgene Corporation, Labeling Revision
• Thalomid (thalidomide) Capsules, Celgene Corporation, Labeling Revision
• Tobradex ST (tobramycin and dexamethasone) Ophthalmic Suspension, Alcon, Inc., Labeling Revision

August 4, 2010

• Actos (pioglitazone hydrochloride) Tablets, Takeda Pharmaceuticals, Labeling Revision
• Amlodipine Besylate and Benazepril Hydrochloride Capsules, Par Pharmaceutical, Inc., Approval
• CardioGen-82 (rubidium chloride rb-82) Injection, Bracco Diagnostics Inc., Efficacy Supplement with Clinical Data to Support
• Creon (pancrelipase) Delayed-Release Capsules, Abbott Products Inc., Efficacy Supplement with Clinical Data to Support
• Mobic (meloxicam) Tablets, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision
• Mobic (meloxicam) Oral Suspension, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision
• Prandin (repaglinide) Tablets, Novo Nordisk Inc., Labeling Revision

July 30, 2010

• Cuvposa (glycopyrrolate) Oral Solution, Shionogi Pharma, Inc., Approval
• Duraclon (clonidine hydrochloride) Injection, Bioniche Pharma, Labeling Revision
• Fludara (fludarabine phosphate) Injection, Genzyme Corporation, Labeling Revision
• Humatrope (somatropin [rDNA origin]) Injection, Eli Lilly and Company, Labeling Revision
• Lastacaft (alcaftadine) Ophthalmic Solution, Vistakon Pharmaceuticals, LLC, Approval
• Percodan (oxycodone hydrochloride and aspirin) Tablets, Endo Pharmaceuticals, Inc., Labeling Revision
• Sporanox (itraconazole) Capsules, Ortho-McNeil-Janssen Pharmaceuticals, Labeling Revision
• Sporanox (itraconazole) Oral Solution, Ortho-McNeil-Janssen Pharmaceuticals, Labeling Revision
• Sprycel (dasatinib) Tablets, Bristol Myers Squibb, Labeling Revision
• Strattera (atomoxetine hydrochloride) Capsules, Eli Lilly and Company, Labeling Revision

July 29, 2010

• Bactrim (sulfamethoxazole and trimethoprim) Tablets, Mutual Pharmaceutical Co., Inc., Labeling Revision 
• Bactrim DS (sulfamethoxazole and trimethoprim) Tablets, Mutual Pharmaceutical Co., Inc., Labeling Revision
• Bisoprolol Fumarate and Hydrochlorothiazide Tablets, Unichem Laboratories Ltd., Approval
• Carboplatin I.V. Injection , Akorn Inc., Approval
• Levetiracetam Tablets, Methapharm, Inc., Approval
• Losartan Potassium Tablets, Actavis, Inc., Tentative Approval
• Orapred ODT (prednisolone sodium phosphate) Orally Disintegrating Tablets, Shionogi Pharma, Inc., Labeling Revision
• Ranitidine Hydrochloride Syrup, Aurobindo Pharma, Approval
• Riluzole Tablets, Glenmark Generics Ltd., Tentative Approval
• Rocuronium Bromide Injection, Sagent Strides LLC., Approval
• Simcor (niacin and simvastatin) Tablets, Abbott Laboratories, Manufacturing Revision
• Sumatriptan Succinate Subcutaneous Injection, Sagent Strides LLC., Approval
• Twynsta (telmisartan and amlodipine besylate) Tablets, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision

July 28, 2010

• Aricept (donepezil hydrochloride) Tablets, Eisai Inc., Approval
• Cyclobenzaprine Hydrochloride Tablets, Invagen Pharmaceuticals, Inc., Approval
• Enoxaparin Sodium Subcutaneous Injection, Sandoz Inc., Approval
• Heparin Sodium Injection, Sagent Pharmaceuticals, Inc., Approval
• Methylphenidate Hydrochloride Oral Solution, Tris Pharma, Inc., Approval
• Relistor (methylnaltrexone bromide) Subcutaneous Solution, Progenics Pharmaceuticals, Inc., Labeling Revision
• Relpax (eletriptan hydrobromide) Tablets, Pfizer Inc., Labeling Revision
• Tribenzor (olmesartan medoxomil, amlodipine and hydrochlorothiazide) Tablets, Daiichi Sankyo, Inc., Approval
• Trisenox (arsenic trioxide) Injection, Cephalon Inc., Labeling Revision

July 27, 2010

• Bupropion Hydrochloride Extended-Release Tablets, Actavis South Atlantic LLC, Approval
• Imitrex (sumatriptan) Nasal Spray, GlaxoSmithKline, Labeling Revision
• Imitrex (sumatriptan succinate) Subcutaneous Injection, GlaxoSmithKline, Labeling Revision
• Megace ES (megestrol acetate) Oral Suspension, Par Pharmaceutical, Approval
• Metoprolol Succinate Extended-Release Tablets, Wockhardt Ltd., Approval
• Mysoline (primidone) Tablets, Valeant Pharmaceuticals International, Labeling Revision
• Norethindrone Tablets, Glenmark Generics Ltd., Approval
• Oxymorphone Hydrochloride Extended-Release Tablets, Impax Laboratories, Inc., Approval
• Podofilox Topical Solution, Collegium Pharmaceutical, Inc., Approval
• Rosuvastatin Calcium Tablets, Sandoz Inc., Tentative Approval 
• Sertraline Hydrochloride Tablets, Actavis Totowa LLC, Approval
• Tygacil (tigecycline) I.V. Injection, Pfizer Pharmaceuticals, Inc., Labeling Revision

July 20, 2010

• Rosuvastatin Calcium Tablets, Sandoz Inc., Tentative Approval

July 19, 2010

• Clonidine Transdermal System, Mylan Technologies, Inc., Approval
• HalfLytely (bisacodyl, polyethylene glycol 3350, potassium chloride, sodium bicarbonate and sodium chloride) Delayed-Release Tablet, Braintree Laboratories, Inc., Efficacy Supplement with Clinical Data to Support
• Montelukast Sodium Chewable Tablets, Torrent Pharmaceuticals Ltd., Tentative Approval
• Mycophenolate Mofetil Tablets, Endo Pharmaceuticals Inc., Approval
• Omeprazole Delayed-Release Tablets, Dexcel Pharma Technologies Ltd., Labeling Revision
• Phentermine Hydrochloride Capsules, Lannett Holdings, Inc., Approval
• Tygacil (tigecycline) I.V. Injection, Pfizer Pharmaceuticals, Inc., Labeling Revision
• Veltin (clindamycin phosphate and tretinoin) Gel, Stiefel, a GSK Co., Approval
• Zyvox (linezolid) Injection, Pfizer Global Pharmaceuticals., Labeling Revision
• Zyvox (linezolid) Oral Suspension, Pfizer Global Pharmaceuticals., Labeling Revision
• Zyvox (linezolid) Tablets, Pfizer Global Pharmaceuticals., Labeling Revision

July 16, 2010

• Accolate (zafirlukast) Tablets, AstraZeneca Pharmaceuticals, LP, Labeling Revision
• Bupropion Hydrochloride Extended-Release Tablets, Mylan Pharmaceuticals, Inc., Approval
• Ergocalciferol Capsules, SigmaPharm Laboratories, LLC, Approval
• Mirapex ER (pramipexole dihydrochloride) Extended-Release Tablets, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision
• Theophylline Extended-Release Tablets, Glenmark Generics, Ltd., Approval

July 13, 2010

• Atomoxetine Hydrochloride Capsules, Dr Reddy's Laboratories Ltd., Tentative Approval
• Desloratadine Orally Disintegrating Tablets, Dr Reddy's Laboratories Ltd., Approval
• Nabumetone Tablets, Matrix Laboratories Ltd., Approval
• Vesicare (solifenacin succinate) Tablets, Astellas Pharma Global Development, Inc., Labeling Revision

July 12, 2010

• Clindamycin Palmitate Hydrochloride Oral Solution, Paddock Laboratories, Inc., Approval
• Lucentis (ranibizumab) Injection, Genentech, Inc., Supplement
• Naratriptan (naratriptan hydrochloride)Tablets, Roxane Laboratories, Inc., Approval
• Naratriptan (naratriptan hydrochloride) Tablets, Sandoz Inc., Approval
• Naratriptan (naratriptan hydrochloride) Tablets, TEVA Pharmaceuticals, Approval
• Onsolis (fentanyl citrate) Oral Soluble Film, Meda Pharmaceuticals, Inc., Labeling Revision
• Pramipexole Dihydrochloride Tablets, Zydus Pharmaceuticals, Approval
• Pramipexole Dihydrochloride Tablets, Sandoz Inc., Approval
• Prilosec OTC (omeprazole magnesium) Delayed Release Tablets, The Proctor & Gamble Company, Labeling Revision
• Ranitidine Hydrochloride Oral Solution, Vintage Pharmaceuticals, Approval
• Tacrolimus Capsules, Watson Laboratories, Inc., Approval
• Zuplenz (ondansetron) Oral Soluble Film, Par Pharmaceutical, Inc., Approval

July 08,  2010

• Doxycycline Capsules, Mylan Pharmaceuticals Inc., Approval
• Gemifloxacin Mesylate Tablets, Orchid Healthcare, Tentative Approval
• Infergen (interferon alfacon-1) Subcutaneous Injection, Three Rivers Pharmaceuticals, LLC, Supplement
• Klaron (sodium sulfacetamide) Lotion, Sanofi-Aventis U.S. LLC, Labeling Revision
• Pulmicort Flexhaler (budesonide) Inhalation Powder, AstraZeneca, Labeling Revision
• Pulmicort Respules (budesonide) Inhalation Suspension, AstraZeneca, Labeling Revision
• Rapamune (sirolimus) Oral Solution, Wyeth Pharmaceuticals, Inc., Labeling Revision
• Rapamune (sirolimus) Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision
• Spironolactone Tablets, Amneal Pharmaceuticals, Approval
• Sutent (sunitinib malate) Capsules, Pfizer, Inc., Efficacy Supplement and Labeling Revision
• Triamcinolone Acetonide Dental Paste, Lyne Laboratories, Inc., Approval

July 2,  2010

• Adapalene Cream, Nycomed US, Inc., Approval
• Agrylin (anagrelide hydrochloride) Capsules, Shire Development, Inc., Labeling Revision
• Alsuma (sumatriptan) Injection, King Pharmaceuticals, Inc., Approval
• Butrans (buprenorphine) Transdermal System, Purdue Pharma L.P., Approval
• Cefepime in Plastic Container (cefepime hydrochloride) Injection, Baxter Healthcare Corp., Labeling Revision
• Daytrana (methylphenidate) Patch, Shire Pharmaceuticals, Labeling Revision
• Daytrana (methylphenidate) Patch, Shire Pharmaceuticals, New or Modified Indication
• Heparin Sodium Injection, Sagent Pharmaceuticals, Inc., Approval 
• Hycamtin (topotecan hydrochloride) Capsules, GlaxoSmithKline, Labeling Revision
• Isentress (raltegravir potassium) Tablets, Merck Sharp & Dohme Corp., Efficacy Supplement with Clinical Data to Support
• Methadone Hydrochloride Oral Solution, VistaPharm, Inc., Approval
• Mevacor (lovastatin) Tablets, Merck & Co., Inc., Labeling Revision  

July 1,  2010

• Clobetasol Propionate Shampoo, Paddock Laboratories, Inc., Tentative Approval
• Desoximetasone Cream, Nycomed US, Inc., Approval
• Famotidine Oral Suspension, Lupin Ltd., Approval
• Losartan Potassium Tablets, Lupin Pharmaceuticals, Inc., Tentative Approval
• Nicotrol NS (nicotine) Nasal Spray, Pfizer, Inc., Labeling Revision
• OxyContin (oxycodone hydrochloride) Extended-Release Tablets, Purdue Pharma L.P., Labeling Revision

June 30,  2010

• Advair Diskus (fluticasone propionate and salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, Labeling Revision 
• Advair HFA (fluticasone propionate and salmeterol xinafoate) Inhalation Aerosol, GlaxoSmithKline, Labeling Revision
• Ceftriaxone and Dextrose in Duplex Container Injection, B. Braun Medical, Inc., Labeling Revision
• Femara (letrozole) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
• Lithium Carbonate Tablets, Sun Pharmaceutical Industries Ltd, Approval
• Novolin R (insulin [rDNA origin]) Injection, Novo Nordisk Inc., Manufacturing Change or Addition
• Novolin N (insulin susp isophane [rDNA origin]) Injection, Novo Nordisk Inc., Manufacturing Change or Addition
• Novolin 70/30 (insulin [rDNA origin] and insulin susp isophane [rDNA origin]) Injection, Novo Nordisk Inc., Manufacturing Change or Addition
• Novolog (insulin aspart [rDNA origin]) Subcutaneous Injection, Novo Nordisk Inc., Manufacturing Change or Addition
• Rybix ODT (tramadol hydrochloride) Orally Disintegrating Tablet, Victory Pharma, Inc., Labeling Revision
• Solu-Medrol (methylprednisolone sodium succinate) Injection, Pfizer Global Research & Development, Labeling Revision
• Serevent (salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, Labeling Revision
• Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Spray, AstraZeneca LP, Labeling Revision 

June 29, 2010

• Acuvail (ketorolac tromethamine) Ophthalmic Solution, Allergan, Inc., Labeling Revision
• Anastrozole Tablets, Accord Healthcare, Inc., USA, Approval
• Anastrozole Tablets, Dr. Reddy’s Laboratories, Ltd., Approval
• Anastrozole Tablets, Natco Pharma Ltd., Approval
• Anastrozole Tablets, Roxane Laboratories, Inc., Approval
• Anastrozole Tablets, Sandoz Inc., Approval
• Anastrozole Tablets, Stason Pharmaceuticals, Inc., Approval
• Anastrozole Tablets, Synthon Pharmaceuticals, Inc., Approval
• Anastrozole Tablets, TEVA Pharmaceuticals USA, Approval
• Anastrozole Tablets, Three Rivers Pharmaceuticals, LLC, Approval
• Anastrozole Tablets, Watson Laboratories, Inc., Approval
• Anastrozole Tablets, Zydus Pharmaceuticals USA, Inc., Approval
• Bactrim (sulfamethoxazole and trimethoprim) Tablets, Mutual Pharmaceutical Co., Inc., Labeling Revision
• Follistim AQ (follitropin alfa/beta) Subcutaneous Injection, Organon USA, Inc., Efficacy Supplement with Clinical Data to Support
• Follistim AQ (follitropin alfa/beta) Subcutaneous Injection, Organon USA, Inc., Efficacy Supplement with Clinical Data to Support
• Risperidone Oral Solution, Precision Dose, Inc., Approval

June 25,  2010

• Acanya (clindamycin phosphate and benzoyl peroxide) Gel, Dow Pharmaceutical Sciences, Inc., Labeling Revision
• Angiomax (bivalirudin) Injection, The Medicines Company, Labeling Revision
• Fentanyl Tablets, Watson Laboratories, Inc., Tentative Approval
• Glipizide and Metformin Hydrochloride Tablets, Indicus Pharma, LLC, Approval
• Hydrocodone Bitartrate and Ibuprofen Tablets, Watson Laboratories, Inc., Approval
• Lorazepam Tablets, Amneal Pharmaceuticals, Approval
• Meropenem Injection, Hospira, Inc., Approval
• Solu-Cortef (hydrocortisone sodium succinate) Injection, Pharmacia & Upjohn Co., Labeling Revision 
• Ultravist (iopromide) Injection, Bayer HealthCare Pharmaceuticals, Inc., Efficacy Supplement with Clinical Data to Support

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

June 3,  2010

• Advil (ibuprofen and phenylepherine hydrochloride) Tablets, Wyeth Consumer Healthcare, Approval
• Anastrozole Tablets, Accord Health Care, Inc., Tentative Approval
• Granisetron Hydrochloride Tablets, Taro Pharmaceuticals Inc., Approval
• Pramipexole Dihydrochloride Tablets, Torrent Pharmaceuticals, Tentative Approval
• Selzentry (maraviroc) Tablets, ViiV Healthcare Co., Efficacy Supplement
• Valproic Acid Syrup, Sun Pharmaceutical Industries, Inc., Approval

June 2,  2010

• Anastrozole Tablets, Three Rivers Pharmaceuticals, LLC, Tentative Approval
• Pravastatin Sodium Tablets, Matrix Laboratories Ltd., Approval
• Prolia (denosumab) Subcutaneous Injection, Amgen, Inc., Approval
• Rizatriptan Benzoate Tablets, Sandoz Inc., Tentative Approval
• Rosuvastatin Calcium Tablets, Par Pharmaceutical, Inc., Tentative Approval
• Zyprexa (olanzapine) Tablets, Eli Lilly and Co., Labeling Revision
• Zyprexa Zydis (olanzapine) Orally Disintegrating Tablets, Eli Lilly and Co., Labeling Revision
• Zyprexa (olanzapine) Intramuscular Injection, Eli Lilly and Co., Labeling Revision
• Zyprexa Relprevv (olanzapine pamoate) Extended-Release Intramuscular Suspension, Eli Lilly and Co., Labeling Revision

June 1,  2010

• Anastrozole Tablets, Dr Reddy's Laboratories Ltd., Tentative Approval
• Famotidine Oral Suspension, Navinta LLC, Approval
• Fluconazole in Dextrose 5% in Plastic Container Injection, Claris Lifesciences Ltd., Approval 
• Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbomate, Potassium Chloride and Bisacodyl Oral Solution and Delayed-Release Tablets, Novel Laboratories, Inc., Tentative Approval
• Today (nonoxynol-9) Sponge, PAV Nova, Inc., Labeling Revision
• Tramadol Hydrochloride Tablets, Northstar Healthcare Holdings Ltd., Approval
• Vaprisol (conivaptan hydrochloride) I.V. Injection, Astellas Pharma US, Inc., Labeling Revision

May 27,  2010

• Cervidil (dinoprostone) Extended-Release Vaginal Insert, Forest Laboratories, Inc., Labeling Revision
• Fluconazole in Sodium Chloride 0.9% Injection, Claris Lifesciences, Ltd., Approval 
• Invanz (ertapenem sodium) Intramuscular I.V. Injection, Merck & Co., Inc., Labeling Revision
• Levetiracetam I.V. Injection, Nexus Pharmaceuticals, Inc., Approval 
• Nasonex (mometasone furoate) Nasal Spray, Schering-Plough, Efficacy Supplement with Clinical Data to Support
• Omeprazole and Sodium Bicarbonate Capsules, Par Pharmaceutical, Inc., Approval
• Trandolapril and Verapamil Hydrochloride Extended-Release Tablets, Glenmark Generics, Ltd., Approval 
• Xenical (orlistat) Capsules, Hoffmann-La Roche, Inc., Labeling Revision

May 26,  2010

• Ciclopirox Shampoo, Nycomed US Inc., Approval
• Wellbutrin (bupropion hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision 
• Wellbutrin SR (bupropion hydrochloride) Extended-Release Tablets, GlaxoSmithKline, Labeling Revision
• Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets, Biovail Technologies, Ltd., Labeling Revision

May 25, 2010

• Valacyclovir Hydrochloride Tablets, Aurobindo Pharma USA, Inc., Approval
• Valacyclovir Hydrochloride Tablets, Dr. Reddy's Laboratories, Ltd., Approval
• Valacyclovir Hydrochloride Tablets, Mylan Pharmaceuticals Inc., Approval
• Valacyclovir Hydrochloride Tablets, Matrix Laboratories Ltd., Approval
• Valacyclovir Hydrochloride Tablets, Roxane Laboratories, Inc., Approval
• Valacyclovir Hydrochloride Tablets, Sandoz Inc., Approval
• Valacyclovir Hydrochloride Tablets, Teva Pharmaceuticals USA, Approval
• Valacyclovir Hydrochloride Tablets, Watson Laboratories, Inc., Approval

May 24,  2010

• Amlodipine Besylate and Benazepril Hydrochloride Capsules, Mylan Pharmaceuticals Inc., Approval
• Chenix (chenodiol) Tablets, Sigma-Tau Pharmaceuticals, Inc., Labeling Revision 
• Levonorgestrel and Ethinyl Estradiol Tablets and Ethinyl Estradiol Tablets, Watson Laboratories, Inc., Tentative Approval
• Losartan Potassium and Hydrochlorothiazide Tablets, Lupin Limited, Tentative Approval and Approval 
• Savella (milnacipran hydrochloride) Tablets, Cypress Bioscience, Inc., Labeling Revision
• Tekturna HCT (aliskiren hemifumarate and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corporation, Labeling Revision

May 20,  2010

• Cefoxitin (cefoxitin sodium) Injection, ACS Dobfar, Approval
• Escitalopram Oxalate Tablets, Mylan Pharmaceuticals, Inc., Tentative Approval 
• Losartan Potassium Tablets, Zydus Pharmaceuticals, Inc., Tentative Approval
• Sprix (ketorolac tromethamine) Nasal Spray, Roxro Pharma, Inc., Approval 
• Zymaxid (gatifloxacin) Ophthalmic Solution, Allergan, Inc., Approval 

May 19,  2010

• Camptosar (irinotecan hydrochloride) Injection, Pfizer, Inc., Labeling Revision
• Parnate (tranylcypromine sulfate) Tablets, GlaxoSmithKline, Labeling Revision
• Remeron (mirtazapine) Tablets, Organon Inc., Labeling Revision
• Remeron SolTab (mirtazapine) Orally Disintegrating Tablets, Organon Inc., Labeling Revision
• Topicort (desoximetasone) Ointment, Taro Pharmaceuticals, Labeling Revision

May 18, 2010

• Lamivudine and Stavudine Tablets, Hetero Drugs Ltd., Tentative Approval
• Retrovir (zidovudine) Capsules, GlaxoSmithKline, Labeling Revision
• Retrovir (zidovudine) Syrup, GlaxoSmithKline, Labeling Revision
• Retrovir (zidovudine) Tablets, GlaxoSmithKline, Labeling Revision
• Savella (milnacipran hydrochloride) Tablets, Cypress Bioscience, Inc., Labeling Revision

May 17,  2010

• Afinitor (everolimus) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
• Alprazolam Extended-Release Tablets, Watson Laboratories, Approval
• Bicalutamide Tablets, Fresenius Kabi Oncology, Approval
• Invega Sustenna (paliperidone palmitate) Extended-Release Intramuscular Suspension, Ortho-McNeil-Jansen Pharmaceuticals, Inc., Labeling Revision
• Letrozole Tablets, Fresenius Kabi Oncology, Tentative Approval 
• Letrozole Tablets, Accord Healthcare, Inc., Tentative Approval 
• Taxotere (docetaxel) Injection, Sanofi-Aventis U.S., Inc., Efficacy Supplement with Clinical Data to Suppport

May 14,  2010

• Abacavir Sulfate Tablets, Strides Arcolab, Ltd., Tentative Approval
• Acyclovir and Hydrocortisone Topical Cream, Medivir, Labeling Revision
• Albuterol Sulfate Syrup, Amneal Pharmaceuticals, Approval
• Budesonide Capsules, Mylan Pharmaceuticals, Inc., Tentative Approval
• Cinacalcet Hydrochloride Tablets, Barr Laboratories, Inc., Tentative Approval
• Fosphenytoin Sodium Injection, Luitpold Pharmaceuticals, Inc., Approval
• Ixempra Kit (ixabepilone) I.V. Injection, Bristol-Myers Squibb Co., Labeling Revision
• Oracea (doxycycline) Capsules, Galderma Laboratories, Labeling Revision
• Oxymorphone Hydrochloride Extended-Release Tablets, Impax Laboratories, Inc., Tentative Approval
• Rosuvastatin Calcium Tablets, Aurobindo Pharma, Tentative Approval
• Rosuvastatin Calcium Tablets, Mylan Pharmaceuticals, Inc., Tentative Approval
• Rosuvastatin Calcium Tablets, TEVA Pharmaceuticals, Tentative Approval 
• Tacrolimus Capsules, Dr. Reddy's Laboratories, Approval   

May 13,  2010

• Bacitracin Injection, Sagent Strides, Approval
• Erythromycin Pledgets, VersaPharm, Inc., Approval
• Estradiol and Norethindrone Acetate Tablets, Barr Laboratories, Inc., Approval
• MS Contin (morphine sulfate) Extended-Release Tablets, Purdue Pharma, LP, Labeling Revision
• Prevacid (lansoprazole) Delayed-Release Capsules, Takeda Pharmaceuticals, Labeling Revision 
• Prevacid (lansoprazole) Delayed-Release Orally Disintegrating Tablets, Takeda Pharmaceuticals, Labeling Revision
• Vecuronium Bromide Injection, Akorn-Strides, Approval 
• Venlafaxine Hydrochloride Tablets, Amneal Pharmaceuticals, Approval 

May 12,  2010

• Bethanechol Chloride Tablets, Emcure Pharmaceuticals USA Inc., Approval
• Buprenorphine Hydrochloride Tablets, Barr Laboratories, Inc., Approval
• Carbinoxamine Maleate Oral Solution, Cypress Pharmaceutical, Inc., Approval
• Cefepime and Dextrose Injection, B. Braun Medical, Inc., Approval
• Droxia (hydroxyurea) Capsules, Bristol-Myers Squibb, Labeling Revision
• Flo-Pred (prednisolone acetate) Oral Suspension, Taro Pharmaceuticals, Manufacturing Change or Addition
• Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules, Novartis Pharmaceuticals Corp., Labeling Revision
• Metronidazole Extended-Release Tablets, Alembic Ltd., Approval
• Miralax (polyethylene glycol 3350) Oral Solution, Schering-Plough HealthCare Products, Inc., Labeling Revision
• NovoLog Mix 70/30 (insulin aspart protamine [rDNA origin] and insulin aspart [rDNA origin]) Subcutaneous Injection, Novo Nordisk Inc., Efficacy Supplement with Clinical Data to Support
• Omnaris (ciclesonide) Nasal Spray, Nycomed US, Labeling Revision
• Relenza (zanamivir) Inhalation Powder, GlaxoSmithKline, Labeling Revision
• Tramadol Hydrochloride Extended-Release Capsules, Wilcox and Savage, Approval
• Trandolapril and Verapamil Hydrochloride Extended-Release Tablets, Glenmark Generics Inc., Approval
• Tylenol (acetaminophen) Extended-Release Tablets, McNeil Consumer Healthcare, Manufacturing Change or Addition

May 11, 2010

• Acephen (acetaminophen) Suppository, G and W Laboratories, Inc., Labeling Revision
• Blenoxane (Bleomycin sulfate) Injection, Bristol-Myers Squibb, Labeling Revision
• Catapres-TTS (clonidine) Patch , Boehringer Ingelheim, Labeling Revision
• Colcrys (colchicine) Tablets, AR Holding Company, Inc., Labeling Revision
• Creon (pancrelipase) Delayed-Release Capsules, Abbott Products, Inc., Patient Population Altered
• Femara (letrozole) Tablets, Novartis Pharmaceuticals Corp.. Efficacy Supplement with Clinical Data to Support
• Hyphanox (itraconazole) Tablets, Stiefel Laboratories, Inc., Approval
• Irinotecan Hydrochloride Injection, Dr. Reddy's Laboratories, Ltd., Approval
• Midol Liquid Gels (ibuprofen) Capsules, Banner Pharmacaps Inc., Labeling Revision
• Norvir (ritonavir) Oral Solution, Abbott Laboratories, Labeling Revision
• Remicade (infliximab) Intravenous Injection, Centocor Ortho Biotech, Inc.,  Supplement
• Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules, Novartis Pharmaceuticals Corp., Labeling Revision
• Ritonavir Tablets, Abbott Laboratories, Labeling Revision
• Sandimmune (cyclosporine) Capsules, Novartis Pharmaceuticals Corp. , Labeling Revision
• Sandimmune (cyclosporine) Injection, Novartis Pharmaceuticals Corp. , Labeling Revision
• Sandimmune (cyclosporine) Oral Solution, Novartis Pharmaceuticals Corp. , Labeling Revision

May 6,  2010

• Aptivus (tipranavir) Capsules, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision
• Invarase (saquinavir mesylate) Capsules, Hoffmann-La Roche Inc., Labeling Revision
• Kaletra (lopinavir and ritonavir) Tablets, Abbott Laboratories, Patient Population Altered
• Kaletra (lopinavir and ritonavir) Oral Solution, Abbott Laboratories, Patient Population Altered
• Norvir (ritonavir) Capsules, Abbott Laboratories, Labeling Revision
• Tamsulosin Hydrochloride Capsules, Synthon Pharmaceuticals, Inc., Approval
• Tamsulosin Hydrochloride Capsules, Sandoz Inc., Approval
• Tamsulosin Hydrochloride Capsules, Zydus Pharmaceuticals Inc., Approval
• Tamsulosin Hydrochloride Capsules, Wockhardt, Approval
• Tamsulosin Hydrochloride Capsules, TEVA Pharmaceuticals, Approval
• Tamsulosin Hydrochloride Capsules, Mylan Pharmaceuticals, Inc., Approval
• Votrient (pazopanib hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision
• Zyprexa Relprevv (olanzapine pamoate) Extended-Release Intramuscular Suspension, Eli Lilly and Company, Labeling Revision

May 4, 2010

• Bupropion Hydrochloride Tablets, Mylan Pharmaceuticals, Inc., Approval
• Flovent Diskus 50 (fluticasone propionate) Inhalation Powder, GlaxoSmithKline, Labeling Revision
• Protriptyline Hydrochloride Tablets, SigmaPharm Laboratories, LLC, Approval

May 3,  2010

• Crixivan (indinavir sulfate) Capsules, Merck Sharp & Dohme Corp., Labeling Revision
• Glimepiride Tablets, Watson Laboratories, Inc., Approval
• Lexiva (fosamprenavir calcium) Tablets, ViiV Healthcare Company, Labeling Revision
• Leukeran (chlorambucil) Tablets, GlaxoSmithKline, Labeling Revision
• Naratriptan Tablets, Sandoz Inc., Tentative Approval
• Omnitrope (somatropin [rDNA origin]) Injection, Sandoz Inc., Efficacy Supplement
• Prezista (darunavir ethanolate) Tablets, Tibotec, Incorporated, Labeling Revision
• Reyataz (atazanavir sulfate) Capsules, Bristol-Myers Squibb Company, Labeling Revision
• Torisel (temsirolimus) I.V. Solution, Wyeth Pharmaceuticals, Inc., Efficacy Supplement
• Viracept (nelfinavir mesylate) Oral Powder, Agouron Pharmaceuticals Inc., Labeling Revision

April 29,  2010

• Cinacalcet Hydrochloride Tablets, TEVA Pharmaceuticals, Tentative Approval
• Chantix (varenicline tartrate) Tablets, Pfizer, Inc., Labeling Revision
• Heather (norethindrone) Tablets, Glenmark Generics Ltd., Approval
• Lansoprazole Delayed-Release Capsules, Sandoz, Inc., Approval
• Losartan (losartan potassium) Tablets, Roxane Laboratories, Inc., Tentative Approval
• Rapamune (sirolimus) Oral Solution, Wyeth Pharmaceuticals, Inc., Labeling Revision
• Rapamune (sirolimus) Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision
• Verdeso (desonide) Foam, Stiefel Laboratories, Inc., Labeling Revision
• Voriconazole Tablets, Matrix Laboratories Ltd., Approval
• Vytorin (ezetimibe and simvastatin) Tablets, MSP Singapore Co., Labeling Revision

April 28, 2010

• Folotyn (pralatrexate) I.V. Solution, Allos Therapeutics, Labeling Revision
• Mobic (meloxicam) Oral Suspension, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision
• Mobic (meloxicam) Tablets, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision
• Singulair (montelukast sodium) Chewable Tablets, Merck and Co., Inc., Labeling Revision
• Singulair (montelukast sodium) Oral Granules, Merck and Co., Inc., Labeling Revision
• Singulair (montelukast sodium) Tablets, Merck and Co., Inc., Labeling Revision
• Temodar (temozolomide) Powder, Schering-Plough Corp., Labeling Revision
• Temodar (temozolomide) Capsules, Schering-Plough Corp., Labeling Revision
• Torisel (temsirolimus) I.V. Solution, Wyeth Pharmaceuticals, Inc., Efficacy Supplement with Clinical Data to Support

April 27,  2010

• Adenosine Injection, Sagent Strides LLC, Tentative Approval
• Amoxicillin and Clavulanate Potassium Extended-Release Tablets, Sandoz Inc., Approval
• Diovan HCT (valsartan and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
• Mavik (trandolapril) Tablets, Abbott Laboratories, Labeling Revision
• Mefloquine Hydrochloride Tablets, West-Ward Pharmaceutical Corp., Approval
• Memantine Hydrochloride Tablets, Upsher-Smith Laboratories, Inc., Tentative Approval
• Metformin Hydrochloride Tablets, Granules India Ltd., Approval
• Methamphetamine Hydrochloride Tablets, Coastal Pharmaceuticals, Approval
• Metoprolol Succinate Extended-Release Tablets, Watson Laboratories, Inc., Approval
• Ondansetron Hydrochloride Injection, Lannett Holdings, Inc., Approval
• Taxotere (docetaxel) Injection, Sanofi-Aventis US Inc., Labeling Revision
• Torsemide Injection, PharmaForce, Inc., Approval
• Ventavis (iloprost) Inhalation Solution, Actelion Pharmaceuticals, Ltd., Labeling Revision
• Zortress (everolimus) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision 

April 20, 2010

• Metoprolol Tartrate Injection, Sagent Strides LLC, Approval
• Montelukast Sodium Chewable Tablets, Roxane Laboratories, Inc., Tentative Approval
• Ondansetron Hydrochloride and Sodium Chloride in Plastic Container Injection, Labeling Revision
• Valtrex (valacyclovir hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision
• Zonegran (zonisamide) Capsules, Eisai Inc., Labeling Revision

April 16,  2010

• Allegra-D 12 Hour (fexofenadine hydrochloride and pseudoephedrinie hydrochloride) Extended-Release Tablets, Sanofi-Aventis, Labeling Revision
• Allegra-D 24 Hour (fexofenadine hydrochloride and pseudoephedrinie hydrochloride) Extended-Release Tablets, Sanofi-Aventis, Labeling Revision
• Ambien CR (zolpidem tartrate) Extended-Release Tablets, Sanofi-Synthelabo Research, Labeling Revision
• Lamictal XR (lamotrigine) Extended-Release Tablets, GlaxoSmithKline, Manufacturing Change or Addition
• Memantine Hydrochloride Tablets, Reddy’s Laboratories Limited, Approval
• Ondansetron Hydrochloride Injection, Lannett Holdings, Inc., Approval 

April 15,  2010

• Calan (verapamil hydrochloride) Tablets, Pfizer, Incorporated, Labeling Revision
• Calan (verapamil hydrochloride) Injection, Pfizer, Incorporated, Labeling Revision
• Calan (verapamil hydrochloride) Injection, Pfizer, Incorporated, Labeling Revision
• Covera HS (verapamil hydrochloride) Extended-Release Tablets, Pfizer, Incorporated, Labeling Revision
• Doral (quazepam) Tablets, Questcor Pharma., Inc., Labeling Revision
• Hydromorphone Hydrochloride Injection, Akorn, Inc., Approval
• Lidoderm (lidocaine) Patch, Teikoku Pharma USA, Inc., Labeling Revision
• Oraqix (lidocaine and prilocaine) Periodontal Gel, Dentsply Pharmaceutical, Inc., Labeling Revision
• Ortho Evra (norelgestromin and ethinyl estradiol) Patch, Johnson & Johnson Pharmaceuticals Research, Labeling Revision
• Pancreaze (pancrelipase) Delayed-Release Capsules, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Approval

April 14,  2010

• Anthelios 40 (ecamsule, avobenzone, octocrylene, and titanium dioxide) Cream, L’Oreal Products, Inc., Labeling Revision
• Delsym (dextromethorphan polistirex) Extended-Release Oral Suspension, Reckitt Benckiser Inc., Labeling Revision
• Didanosine Delayed-Release Capsules, Matrix Laboratories Limited, Approval
• Donepezil Hydrochloride Orally Disintegrating Tablets, Barr Laboratories, Inc., Tentative Approval
• Granisetron Hydrochloride Injection, Sagent Strides, Approval
• Pramipexole Dihydrochloride Tablets, Mylan Pharmaceuticals, Inc., Approval
• Uroxatral (alfuzosin hydrochloride) Extended-Release Tablets, sanofi-aventis U.S., LLC, Labeling Revision
• Venlafaxine Hydrochloride Tablets, Auroblndo Pharma Limited, Approval
• Yasmin (drospirenone and ethinyl estradiol) Tablets, Bayer HealthCare Pharmaceuticals Inc., Labeling Revision
• Yaz (drospirenone and ethinyl estradiol) Tablets, Bayer HealthCare Pharmaceuticals Inc., Labeling Revision
• Zocor (simvastatin) Tablets, Merck & Co., Inc., Labeling Revision

April 13, 2010

• Gyne-Lotrimin (clotrimazole) Vaginal Cream, Schering-Plough HealthCare Products, Inc., Labeling Revision
• Gyne-Lotrimin 3 (clotrimazole) Vaginal Cream, Schering-Plough HealthCare Products, Inc., Labeling Revision
• Losartan Potassium Tablets, Torrent Pharmaceuticals Ltd., Tentative Approval
• Ondansetron Orally Disintegrating Tablets, Aurobindo Pharma USA, Inc., Approval
• Tev-Tropin (somatropin [rDNA origin]), Injection, Ferring Pharmaceuticals, Inc., Labeling Revision

April 12,  2010

• Amlodipine Besylate Tablets, Vintage Pharmaceuticals, LLC, Approval
• Bupropion Hydrochloride Extended-Release Tablets, Mylan Pharmaceuticals, Inc., Approval
• Memantine Hydrochloride Tablets, Sun Pharma Global, Tentative Approval

April 8,  2010

• Bupropion Hydrochloride Extended-Release Tablets, Sun Pharmaceutical Industries, Inc., Approval
• Catapres (clonidine hydrochloride)  Tablets, Boehringer Ingelheim, Labeling Revision
• Cetirizine Hydrochloride Capsules, Banner Pharmacaps, Inc., Manufacturirng Change or Addition
• Losartan Potassium and Hydrochlorothiazide Tablets, Mylan Pharmaceuticals, Inc., Approval
• Losartan Potassium and Hydrochlorothiazide Tablets, Roxane Laboratories, Inc., Approval 
• Losartan Potassium Tablets, Upsher-Smith Laboratories, Inc., Tentative Approval

April 7, 2010

• Flumadine (rimantadine hydrochloride) Tablets, Caraco Pharmaceutical Laboratories Ltd., Labeling Revision
• Losartan Potassium Tablets, Teva Pharmaceuticals USA, Approval
• Losartan Potassium and Hydrochlorothiazide Tablets, Teva Pharmaceuticals USA, Approval

April 6,  2010

• Albuterol Sulfate Inhalation Solution, Apotex Inc., Approval
• Cystadane (betaine anhydrous) Oral Solution, Rare Disease Therapeutics, Inc., Labeling Revision
• FeverAll (acetaminophen) Rectal Suppositories, Actavis Mid Atlantic LLC, Labeling Revision
• Levofloxacin Tablets, Sandoz, Inc., Tentative Approval
• OxyContin (oxycodone hydrochloride) Controlled-Release Tablets, Purdue Pharma L.P., Approval
• Suprane (desflurane) Liquid Inhalation, Baxter Healthcare Corporation, Labeling Revision
• Vyvanse (lisdexamfetamine dimesylate) Capsules, Shire Pharmaceuticals, Inc., Efficacy and Labeling Revision

April 5,  2010

• Amlodipine and Valsartan Tablets, Synthon Pharmaceuticals, Inc., Tentative Approval
• Memantine Hydrochloride Tablets, Mylan Pharmaceuticals Inc., Tentative Approval
• Propylthiouracil Tablets, Dava Pharmaceuticals, Inc., Labeling Revision
• Tenofovir Disoproxil Fumarate Tablets, InvaGen Pharmaceuticals, Inc., Tentative Approval
• Toviaz (fesoterodine fumarate) Extended Release Tablets, Pfizer Global Research and Development, Labeling Revision
• Verelan PM (verapamil hydrochloride) Extended-Release Capsules, Elan Drug Delivery, Inc., Labeling Revision  

April 2,  2010

• Advicor (niacin and lovastatin) Extended-Release Tablets, Abbott Laboratories, Manufacturing Change or Addition
• Metaxalone Tablets, Sandoz, Inc., Approval
• Patanase (olopatadine hydrochloride) Nasal Spray, Alcon Research, Ltd., Efficacy Supplement with Clinical Data to Support
• Sustiva (efavirenz) Tablets, Bristol-Myers Squibb Co., Labeling Revision
• Sustiva (efavirenz) Capsules, Bristol-Myers Squibb Co., Labeling Revision
• Taclonex (calcipotriene and betamethasone dipropionate) Ointment, LEO Pharmaceuticals Products, Ltd., Labeling Revision
• Verelan (verapamil hydrochloride) Extended-Release Capsules, Elan Drug Delivery, Inc., Labeling Revision
• Vusion (miconazole nitrate, zinc oxide and white petrolatum) Ointment, Stiefel Laboratories, Inc., Labeling Revision

April 1,  2010

• Abacavir Sulfate and Lamivudine Tablets, Teva Pharmaceuticals, Tentative Approval
• Asclera (polidocanol) Injection, Chemische Fabrik Kreussler & Co., Approval
• Clindamycin Phosphate Foam, Cobrek Pharmaceuticals, Inc., Approval
• Exforge (amlodipine besylate and valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
• Isoptin SR (verapamil hydrochloride) Extended-Release Tablets, Ranbaxy Laboratories Ltd., Labeling Revision
• Moexipril Hydrochloride Tablets, Glenmark Generics Ltd., Approval 

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