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                  CDER News Archive
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December 30, 2009

  • Arixtra (fondaparinux sodium) Subcutaneous Injection, GlaxoSmithKline, Labeling Revision
  • Atomoxetine Hydrochloride, Capsules, Glenmark Generics Ltd., Tentative Approval
  • Fragmin (dalteparin sodium) Subcutaneous Injection, Eisai Inc., Labeling Revision
  • Innohep (tinzaparin sodium) Injection, Celgene Corp., Labeling Revision
  • Lexiscan (regadenoson) Intravenous Solution, Astellas Pharma US, Inc., Labeling Revision
  • Lovenox (enoxaparin sodium) Subcutaneous Injection, Sanofi-Aventis, Labeling Revision

December 24, 2009

  • Amlodipine besylate/Benazepril hydrochloride Capsules, Novartis Pharmaceuticals Corporation, Manufacturing Change or Addition
  • Ampicillin and Sulbactam Injection, ACS Dobfar, Approval
  • Carvedilol Tablets, Wockhardt Limited, Approval
  • Ciprofloxacin Injection, Hikma Farmaceutica, Approval
  • Epirubicin Hydrochloride Injection, EBEWE Pharma, Approval
  • Etomidate Injection, PharmaForce, Inc., Approval
  • Flomax (tamsulosin hydrochloride) Capsules, Boehringer Ingelheim Pharmaceuticals, Inc., Efficacy Supp. w/Clinical Data
  • Fuzeon (enfuvirtide) Injection, Hoffmann-La Roche, Inc., Labeling Revision
  • Gemcitabine Injection, Watson Laboratories, Inc., Tentative Approval
  • Mycophenolate Mofetil Capsules, Endo Pharmaceuticals, Inc., Approval
  • Neoprofen (ibuprofen lysine) Injection, Lundbeck Inc., Labeling Revision
  • Pramipexole Dihydrochloride Tablets, Glenmark Generics Limited, Tentative Approval 
  • Risperidone Orally Disintegrating Tablets, Sandoz Inc., Approval
  • Topamax (topiramate) Tablets, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Labeling Revision and Efficacy Supp.
  • Topamax (topiramate) Sprinkle Capsules, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Labeling Revision and Efficacy Supp. 

December 22, 2009

  • Bicillin C-R (penicillin G benzathine, pencillin G procraine) Injection, King Pharmaceuticals, Labeling Revision
  • Bicillin L-A (penicillin G benzathine) Injection, King Pharmaceuticals, Labeling Revision
  • Cromolyn Sodium Oral Concentrate, Genera Pharmaceuticals, Approval

December 18, 2009

December 17, 2009

  • Daytrana (methylphenidate) Patch,Shire Development, Inc., Labeling Revision
  • Verelan PM (verapamil hydrochloride) Extended-Release Capsules, Elan Drug Delivery, Inc., Labeling Revision

December 16, 2009

  • Arranon (nelarabine) I.V. Injection, GlaxoSmithKline, Labeling Revision
  • Stromectol (ivermectin) Tablets, Merck and Co., Inc., Labeling Revision

December 15, 2009

December 10, 2009

December 9, 2009

  • Gemcitabine Injection, Teva Parenteral Medicines, Inc., Tentative Approval
  • Levetiracetam Tablets, Mylan Pharmaceuticals Inc., Approval
  • Rosiglitazone Maleate Tablets, Hikma Pharmaceuticals, Tentative Approval
  • Zyvox (linezolid) Tablets, Pfizer Global Pharmaceuticals, Labeling Revision
  • Zyvox (linezolid) Injection, Pfizer Global Pharmaceuticals, Labeling Revision
  • Zyvox (linezolid) Oral Suspension, Pfizer Global Pharmaceuticals, Labeling Revision

December 7, 2009

  • Chloroquine Phosphate Tablets, Ohm Laboratories, Inc., Approval
  • Fentora (fentanyl citrate) Tablet, Cephalon, Inc., Labeling Revision
  • Fosphenytoin Sodium Injection, Hikma Farmaceutica, Approval
  • Levofloxacin Tablets, Mylan Pharmaceuticals Inc., Tentative Approval
  • Seroquel (quetiapine fumarate) Tablets, AstraZeneca Pharmaceuticals LP, Efficacy Supp. w/Clinical Data
  • Seroquel XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca, Efficacy Supp. and Labeling Revision
  • Vyvanse (lisdexamfetamine dimesylate) Capsules, Shire Pharmaceuticals, Labeling Revision 
  • Zyprexa (olanzapine) Tablets, Eli Lilly and Company, Efficacy Supp. w/Clinical Data 

December 3, 2009

  • Adrenaclick (epinephrine injection) Single-Dose Auto-Injector, Sciele Pharma, Inc., Manufacturing Change or Addition
  • Kalbitor (ecallantide) Injection, Dyax Corporation, Approval 
  • ORTHO EVRA (norelgestromin and ethinyl estradiol) Patch, Johnson & Johnson Pharmaceuticals Research & Development, Labeling Revision
  • Patanase (olopatadine hydrochloride) Nasal Spray, Alcon Research, Ltd., Efficacy Supp. w/Clinical Data
  • Xenazine (tetrabenazine) Tablets, Biovail Americas Corporation, Labeling Revision
  • Zegerid (omeprazole and sodium bicarbonate) Capsules, Schering-Plough Healthcare Products, Inc., Approval 

December 2, 2009

  • Atomoxetine Hydrochloride Capsules, Mylan Pharmaceuticals, Inc., Tentative Approval
  • Atomoxetine Hydrochloride Capsules, Sandoz Inc., Tentative Approval
  • Atomoxetine Hydrochloride Capsules, Sun Pharma Global, Tentative Approval
  • Atomoxetine Hydrochloride Capsules, TEVA Pharmaceuticals, Tentative Approval
  • Ciclopirox Shampoo, Paddock Laboratories, Inc., Approval
  • Divalproex Sodium Delayed-Release Tablets, Vintage Pharmaceuticals, LLC, Approval
  • Glucovance (glyburide and metformin hydrochloride) Tablets, Bristol-Myers Squibb Co., Labeling Revision
  • Intelence (etravirine) Tablets, Tibotec, Inc., Efficacy Supplement with Clinical Data to Support
  • Methadone Hydrochloride Tablets, The PharmaNetwork LLC, Approval
  • Nexcede (ketoprofen) Oral Soluble Film, Novartis Consumer Health, Inc., Approval
  • Parnate (tranylcypromine sulfate) Tablets, GlaxoSmithKline, Labeling Revision
  • Risperidone Orally Disintegrating Tablets, Dr. Reddy’s Laboratories Ltd., Chemistry New Strength 
  • Urso 250 (ursodiol) Tablets, Axcan Scandipharm, Inc., Labeling Revision
  • Urso Forte (ursodiol) Tablets, Axcan Scandipharm, Inc. Labeling Revision
  • Vagifem (estradiol) Vaginal Tablets, Novo Nordisk Pharmaceuticals, Inc., Efficacy Suppement with Clinical Data to Support

December 1, 2009

  • Avelox (moxifloxacin hydrochloride) Tablets, Bayer HealthCare Pharmaceuticals, Inc., Labeling Revision
  • Aveloxin Sodium Chloride 0.8% in Plastic Container (moxifloxacin hydrochloride) I.V. Injection, Bayer HealthCare Pharmaceuticals, Inc., Labeling Revision
  • Norvir (ritonavir) Capsules, Abbott Laboratories, Labeling Revision
  • Norvir (ritonavir) Oral Solution, Abbott Laboratories, Labeling Revision

November 23, 2009

  • ABILIFY (aripiprazole) Tablets, Otsuka Pharmaceutical Company, Ltd., Efficacy Supp. w/Clinical Data
  • Altace (ramipril) Tablets, King Pharmaceuticals, Inc., Labeling Revision
  • Caffeine Citrate Oral Solution, Luitpold Pharmaceuticals, Inc., Approval
  • Calcipotriene Topical Solution, Tolmar, Inc., Approval
  • Cefotaxime Sodium Injection, Aurobindo Pharma Ltd., Approval
  • Cleocin Hydrochloride (clindamycin hydrochloride) Capsules, Pharmacia & Upjohn Co., Labeling Revision
  • Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules, Lilly Research Laboratories, Efficacy Supp. w/Clinical Data
  • Ketorolac Tromethamine Ophthalmic Solution, Sun Pharma Global Inc., Approval
  • Lopinavir and Ritonavir Tablets, Cipla Ltd., Tentative Approval
  • Lopressor (metoprolol tartrate) Injection, Novartis Pharmaceuticals Corp., Labeling Revision
  • Lopressor (metoprolol tartrate) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
  • Qualaquin (quinine sulfate) Capsules, AR Holding Company, Inc., Labeling Revision
  • REYATAZ (atazanavir sulfate) Capsules, Bristol-Myers Squibb Co., Efficacy Supp. w/Clinical Data
  • SELZENTRY (maraviroc) Tablets, ViiV Healthcare Company, Efficacy Supp. w/Clinical Data
  • Vytorin (ezetimibe/simvastatin) Tablets, MSP Singapore Company, LLC, Labeling Revision

November 20, 2009

  • Acetaminophen Extended-Release Tablets, Ranbaxy Laboratories, Ltd., Approval
  • Actoplus Met (pioglitazone hydrochloride and metformin hydrochloride) Tablets, Takeda Global Research & Development Center, Inc., Labeling Revision
  • Calcipotriene Topical Solution, Hi-Tech Pharmacal Co., Inc., Approval
  • Ciprofloxacin in Dextrose 5% in Plastic Container Injection, West-Ward Pharmaceutical Corp., Approval
  • Cordarone (amiodarone hydrochloride) Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision
  • Dorzolamide Hydrochloride Ophthalmic Solution, PharmaForce, Inc., Approval
  • Dorzolamide Hydrochloride and Timolol Mealeate Ophthalmic Solution, Alcon Research, Ltd., Approval
  • Geodon (ziprasidone hydrochloride) Capsules, Pfizer, Inc., Efficacy Supplement with Clinical Data to Support
  • Lamisil AT (terbinafine hydrochloride) Topical Cream, Novartis Consumer Health, Labeling Revision
  • Nizatidine Oral Solution, Amneal Pharmaceuticals, Approval
  • Revatio (sildenafil) Injection, Pfizer, Inc., Approval 
  • Vimpat (lacosamide) Tablets, Schwarz Biosciences, Inc., Labeling Revision
  • Vimpat (lacosamide) Injection, Schwarz Biosciences, Inc., Labeling Revision 

November 19, 2009

November 18, 2009

November 16, 2009

  • Eovist (gadoxetate disodium) Injection, Bayer HealthCare Pharmaceuticals, Manufacturing Change or Addition
  • Imatinib Mesylate Tablets, Sun Pharmaceutical Industries Ltd., Tentative Approval 
  • Nucynta (tapentadol hydrochloride) Tablets, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Labeling Revision
  • REBETOL (ribavirin) Oral Solution, Schering Corporation, Labeling Revision
  • Rheumatrex (methotrexate sodium) Tablets, Dava Pharmaceuticals, Inc., Manufacturing Change or Addition
  • Tramadol Hydrochloride Extended-Release Tablets, Par Pharmaceutical, Inc., Approval
  • Ultravist (iopromide) Injection, Bayer HealthCare Pharmaceuticals, Manufacturing Change or Addition
  • Ultravist (iopromide) Injection Pharmacy Bulk Packaging, Bayer HealthCare Pharmaceuticals, Manufacturing Change or Addition

November 13, 2009

  • Actiq (fentanyl citrate) Lozenges, Cephalon, Labeling Revision
  • Azithromycin Injection, Generamedix, Approval
  • Benzonatate Capsules, Mikart, Approval
  • Catapres (clonidine hydrochloride) Tablets, Boehringer Ingelheim, Labeling Revision
  • Catapres TTS (clonidine) Film, Boehringer Ingelheim, Labeling Revision
  • Ciclopirox Topical Cream, Glenmark Pharmaceuticals, Approval
  • Cetirizine hydrochloride Syrup, Sun Pharmaceutical Industries, Approval
  • Effexor (venlafaxine hydrochloride) Tablets, Wyeth Pharmaceuticals, Labeling Revision
  • Geodon (ziprasidone hydrochloride) Capsules, Pfizer, Labeling Revision
  • Helidac bismuth subsalicylate; metronidazole; tetracyline hydrochloride Chewable Tablets & Capsules, Prometheus Laboratories, Labeling Revision
  • Irinotecan hydrochloride Injection, Ebewe Pharmaceutical, Approval
  • Lansoprazole Delayed-Release Capsules, Teva Pharmaceuticals, Approval
  • Lotensin (benazepril/hydrochlorothiazide) Tablets, Novartis, Labeling Revision
  • Perindopril erbumine Tablets, Aurobindo Pharmaceutical, Approval
  • Perindopril erbumine Tablets, Ivax Pharmaceuticals, Approval
  • Perindopril erbumine Tablets, Roxane, Approval
  • Plavix (clopidogrel bisulfate) Tablets, Sanofi Aventis, Labeling Revision
  • Pristiq (desvenlafaxine succinate) Tablets, Wyeth Pharmaceuticals, Labeling Revision
  • Protonix (pantoprazole sodium) Delayed-Release Oral Suspension, Wyeth Pharmaceuticals, Labeling Revision
  • Protonix (pantoprazole sodium) Delayed-Release Tablets, Wyeth Pharmaceuticals, Labeling Revision & Patient Population Altered
  • Rebetol (ribavirin) Oral Solution, Schering, Labeling Revision
  • Sensipar (cinacalcet hydrochloride) Tablets, Amgen, Labeling Revision
  • Soma compound with codeine Tablets, Meda Pharmaceuticals, Labeling Revision
  • Tapentadol hydrochloride Tablets, Ortho McNeil Janssen, Labeling Revision
  • Tekturna (aliskiren hemifumarate) Tablets, Novartis, Labeling Revision
  • Viread (tenofovir disoproxil fumarate) Tablets, Gilread, Labeling Revision
  • Zometa (zoledronic acid) Infusion, Novartis, Labeling Revision

November 12, 2009

  • Lotensin HCT (benazepril/hydrochlorothiazide) Tablets, Novartis, Labeling Revision
  • Pennsaid (diclofenac sodium) Topical Solution, Nuvo Research, Approval

November 6, 2009

  • Clinimix 2.75/10 Sulfite Free in Dextrose (amino acids and dextrose) Injection, Baxter Healthcare, Labeling Revision
  • Clinimix E 5/25 Sulfite Free with Elect in Dextrose (amino acids, calcium chloride, dextrose, magnesium chloride, potassium phosphate, dibasic, sodium acetate, and sodium chloride) Injection, Baxter Healthcare, Labeling Revision
  • Istodax (romidepsin) Single-Use Vial, Gloucester Pharmaceuticals, Inc., Approval
  • Reyataz (atazanavir sulfate) Capsules, Bristol Myers Squibb, Efficacy Supplement with Clinical Data to Support

November 5, 2009

  • Concerta (methylphenidate hydrochloride) Extended-Release Tablets, Johnson & Johnson Pharmaceutical Research & Development, Efficacy Supp. w/Clinical Data
  • Entereg (alvimopan) Capsules, Adolor Corporation, Labeling Revision
  • Fentanyl  Citrate Oral Lozenge, Mallinckrodt Inc., Approval
  • ISENTRESS (raltegravir potassium) Tablets, Merck & Co., Inc., Labeling Revision 
  • Lialda (mesalamine) Delayed-Release Tablets, Shire Development Inc., Labeling Revision
  • Lamotrigine Tablets, Aurobindo Pharma Limited, Approval
  • MIACALCIN (calcitonin and salmon) Injection, Novartis Pharmaceuticals Corporation, Labeling Revision
  • MIACALCIN (calcitonin and salmon) Nasal Spray, Novartis Pharmaceuticals Corporation, Labeling Revision
  • Omeprazole and Sodium Bicarbonate Capsules, Par Pharmaceutical, Inc., Tentative Approval
  • Relistor (methylnaltrexone bromide) Subcutaneous Injection, Progenics Pharmaceuticals, Inc., Labeling Revision

 

November 4, 2009

 

October 30, 2009

    • Anthelios 40 (ecamsule, avobenzone, octocrylene, and titanium dioxide) Topical Cream, L’Oreal USA, Efficacy Supplement with Clinical Data to Support
    • Flomax (tamsulosin hydrochloride) Capsules, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision
    • Levetiracetam Oral Solution, Amneal Pharmaceuticals, Approval
    • Melphalan Hydrochloride Injection, GeneraMedix, Inc., Approval

 

October 29, 2009

    • ARZERRA (ofatumumab) Injection, GlaxoSmithKine, Approval
    • Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules, Novartis Pharmaceuticals Corporation, Efficacy Supp. w/Clinical Data
    • Lotrel (amlodipine besylate and benazepril hydrochloride) Capsules, Novartis Pharmaceuticals Corporation, Labeling Revision
    • Norpramin (desipramine hydrochloride) Tablets, Sanofi-Aventis US, Inc., Labeling Revision 
    • Risperidone Orally Disintegrating Tablets, Par Pharmaceutical, Inc., New Strength 

 

October 23, 2009

    • Atacand (candesartan cilexetil) Tablets, AstraZeneca, Efficacy Supplement with Clinical Data to Support
    • Actoplus Met (pioglitazone hydrochloride and metformin hydrochloride) Tablets, Takeda Global Research & Development Center, Inc., Supplement
    • Chenodiol Tablets, Nexgen Pharma, Inc., Approval
    • Risperidone Tablets, Synthon Pharmaceuticals, Inc., Approval

 

October 21, 2009

    • Albenza (albendazole) Tablets, GlaxoSmithKline, Labeling Revision
    • Atomoxetine Hydrochloride Capsules, Zydus Pharmaceuticals USA, Inc., Tentative Approval
    • Azulfidine (sulfasalazine) Tablets, Pharmacia & Upjohn Co., Labeling Revision
    • Azulfidine EN-Tabs (sulfasalazine) Tablets, Pharmacia & Upjohn Co., Labeling Revision
    • Chantix (varenicline tartrate) Tablets, Pfizer, Inc., Labeling Revision
    • Chlorothiazide Sodium Injection, APP Pharmaceuticals, LLC, Approval
    • Colcrys (colchicine) Tablets, Mutual Pharmaceutical Co., Inc., Approval
    • Hepsera (adefovir dipivoxil) Tablets, Gilead Sciences, Inc., Labeling Revision
    • Micardis (telmisartan) Tablets, Boehringer Ingelheim Pharmaceuticals, Inc., New or Modified Indication
    • Perindopril Erbumine Tablets, Roxane Laboratories, Inc., Tentative Approval

 

October 20, 2009

    • Locoid Lipocream (hydrocortisone butyrate) Topical Cream, Triax Pharmaceuticals, Efficacy Supplement with Clinical Data to Support
    • Votrient (pazopanib hydrochloride) Tablets, GlaxoSmithKline, Approval  

 

October 19, 2009

    • Banzel (rufinamide) Tablets, Eisai Medical Research, Inc., Labeling Revision
    • Crestor (rosuvastatin calcium) Tablets, IPR Pharmaceuticals, Inc., Efficacy Supplement with Clinical Data to Support
    • Crixivan (indinavir sulfate) Capsules, Merck & Co., Inc., Labeling Revision
    • Depakote (divalproex sodium) Extended-Release Tablets, Abbott Laboratories, Efficacy Supplement with Clinical Data to Support
    • Fentanyl Transdermal System, Hisamitsu Pharmaceutical Co., Inc., Approval
    • Risperidone Tablets, Sandoz, Inc., Approval

 

October 16, 2009

 

October 15, 2009

    • Aggrenox (aspirin and dipyridamole) Extended-Release Capsules, Boehringer-Ingelheim, Efficacy Supp w/Clinical Data
    • Heparin Sodium Injection, Baxter Healthcare Corporation, Labeling Revision
    • INVANZ (ertapenem sodium) Intramuscular I.V. Injection, Merck & Co., Inc., Labeling Revision
    • Mirena (levonorgestrel) Intrauterine System, Bayer HealthCare Pharmaceuticals, Inc., Efficacy Supp w/Clinical Data
    • Monistat 3 (miconazole nitrate) Vaginal Cream, Johnson & Johnson Healthcare Products, Manufacturing Change or Addition
    • MultiHance (gadobenate dimeglumine) Intravenous Injection, Bracco Diagnostics, Inc., Labeling Revision
    • Pulmicort Respules (budesonide) Inhalation Suspension, AstraZeneca, Labeling Revision
    • Risperidone Orally Disintegrating Tablet, Dr. Reddy's Laboratories Ltd., Supplement
    • Tamsulosin Hydrochloride Capsules, IMPAX Laboratories, Inc. Tentative Approval
    • Topiramate Capsules, Mylan Pharmaceuticals Inc., Approval

 

October 14, 2009

    • Anzemet (dolasetron mesylate) Injection,  Sanofi-Aventis U.S. LLC, Labeling Revision
    • Anzemet (dolasetron mesylate) Tablets,  Sanofi-Aventis U.S. LLC, Labeling Revision
    • Ketorolac Tromethamine Ophthalmic Solution, Akorn, Inc., Tentative Approval
    • Ketorolac Tromethamine Ophthalmic Solution, Akorn, Inc., Tentative Approval
    • OsmoPrep (sodium phosphate, dibasic anhydrous, sodium phosphate, monobasic and monohydrate) Tablets, Salix Pharmaceuticals, Inc., Labeling Revision
    • Polyethylene Glycol 3350 Oral Solution, Mylan Pharmaceuticals, Inc., Approval
    • Visicol (sodium phosphate, dibasic anhydrous, sodium phosphate, monobasic and monohydrate) Tablets, Salix Pharmaceuticals, Inc., Labeling Revision

 

October 13, 2009

    • Clonidine Hydrochloride Injection, PharmaForce, Inc., Approval
    • Delsym (dextromethorphan polistirex) Extended-Release Oral Suspension, Reckitt Benckiser, Inc., Labeling Revision
    • Fluocinonide Topical Cream, Perrigo Israel Pharmaceuticals, Ltd., Tentative Approval
    • Losartan Potassium and Hydrochlorothiazide Tablets, Apotex Inc., Tentative Approval
    • Neoral (cyclosporine) Capsules, Novartis Pharmaceuticals Corp., Labeling Revision
    • Neoral (cyclosporine) Oral Solution, Novartis Pharmaceuticals Corp., Labeling Revision
    • Nexium (esomeprazole magnesium) Delayed-Release Capsules, AstraZeneca, Labeling Revision
    • Nexium (esomeprazole magnesium) Delayed-Released Oral Solution, AstraZeneca, Labeling Revision
    • Risperidone Oral Solution, Wockhardt Ltd., Approval
    • Sumatriptan Succinate Subcutaneous Injection, Par Pharmaceutical, Inc., Approval

 

October 9, 2009

    • Buprenorphine Hydrochloride Tablets, Roxane Laboratories, Inc., Approval
    • CellCept (mycophenolate mofetil) Capsules, Roche Palo Alto, LLC, Labeling Revision
    • CellCept (mycophenolate mofetil) Tablets, Roche Palo Alto, LLC, Labeling Revision
    • CellCept (mycophenolate mofetil hydrochloride) Injection, Roche Palo Alto, LLC, Labeling Revision
    • CellCept (mycophenolate mofetil) Oral Suspension, Roche Palo Alto, LLC, Labeling Revision
    • Myfortic (mycophenolic acid) Delayed-Release Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
    • Rapamune (sirolimus) Oral Solution, Wyeth Pharmaceuticals, Inc., Labeling Revision
    • Rapamune (sirolimus) Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision
    • Sandimmune (cyclosporine) Injection, Novartis Pharmaceuticals Corp., Labeling Revision
    • Sandimmune (cyclosporine) Oral Solution, Novartis Pharmaceuticals Corp., Labeling Revision
    • Sandimmune (cyclosporine) Capsules, Novartis Pharmaceuticals Corp., Labeling Revision

 

October 8, 2009

    • Cetirizine Hydrochloride Oral Solution, Amneal Pharmaceuticals, Approval
    • Kytril (granisetron hydrochloride) Injection, Hoffmann-La Roche, Inc., Labeling Revision
    • Kytril (granisetron hydrochloride) Oral Solution, Hoffmann-La Roche, Inc., Labeling Revision
    • Kytril (granisetron hydrochloride) Tablets, Hoffmann-La Roche, Inc., Labeling Revision
    • Polyethylene Glycol 3350 Powder for Solution, Nexgen Pharma, Inc., Approval
    • Viread (tenofovir disoproxil fumarate) Tablets, GILEAD SCIENCES, INC., Efficacy Supplement 

 

October 2, 2009

    • Alfuzosin Hydrochloride Extended-Release Tablets, Wockhardt, Ltd., Tentative Approval
    • Carbidopa and Levodopa Tablets, Mylan Pharmaceuticals, Inc., Approval
    • Cilostazol Tablets, Breckenridge Pharmaceutical, Inc., Approval
    • Cordarone (amiodarone hydrochloride) Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision
    • DepoDur (morphine sulfate) Liposome Injection, Pacira Pharmaceuticals, Inc., Labeling Revision
    • Invega Sustenna (paliperidone palmitate) Extended-Release Intramusculuar Suspension, Ortho-McNeil-Jansen Pharmaceuticals, Inc., Approval
    • Kayexalate (sodium polystyrene sulfonate) Oral or Rectal Powder, sanofi-aventis U.S., LLC, Labeling Revision
    • Lithium Carbonate Capsules, InvaGen Pharmaceuticals, Inc., Approval
    • Maxipime (cefepime hydrochloride) Injection, Bristol-Myers Squibb Co., Labeling Revision
    • Metoprolol Tartrate Injection, Luitpold Pharmaceuticals, Inc., Approval
    • Ondansetron Hydrochloride Injection, Gland Pharma, Ltd., Approval
    • Oxaliplatin Injection, Hospira Worldwide, Inc., Approval
    • Renvela (sevelamer carbonate) Oral Suspension, Genzyme Corp., Approval
    • Stelara (ustekinumab) Injection, Centocor Ortho Biotech, Inc., Approval
    • Zoledronic Acid Injection, Bedford Laboratories, Tentative Approval

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