Center for Drug Evaluation and Research

 

                                                                      

Latest from CDER   Recent Drug Approvals    (use custom search above for pharma news) February 2, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Amturnide aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide Tablet; Oral Novartis Labeling Revision E.E.S. erythromycin ethylsuccinate Granule; Oral Arbor Pharms Inc Labeling Revision Eryped erythromycin ethylsuccinate Granule; Oral Arbor Pharms Inc Labeling Revision Erythrocin erythromycin lactobionate Injectable; Injection Hospira Labeling Revision Pce erythromycin Tablet, Coated Particles; Oral Arbor Pharms Inc Labeling Revision Ropinirole ropinirole Tablet, Extended Release; Oral Dr Reddys Labs Ltd Tentative Approval Tekamlo aliskiren hemifumarate; amlodipine besylate Tablet; Oral Novartis Labeling Revision Valturna aliskiren hemifumarate; valsartan Tablet; Oral Novartis Labeling Revision   February 1, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Atorvastatin Calcium atorvastatin calcium Tablet; Oral Matrix Labs Ltd Tentative Approval Cosopt Pf dorzolamide hydrochloride; timolol maleate Solution/Drops; Ophthalmic Merck Sharp Dohme Approval Implanon etonogestrel Implant; Implantation Organon Usa Inc Labeling Revision Minocycline Hydrochloride minocycline hydrochloride Tablet, Extended Release; Oral Mylan Labs Tentative Approval Nexplanon etonogestrel Implant; Implantation Organon Usa Inc Labeling Revision Nicorette nicotine polacrilex Gum, Chewing; Buccal Glaxosmithkline Labeling Revision Nicorette nicotine polacrilex Gum, Chewing; Buccal Glaxosmithkline Labeling Revision Nicorette (Mint) nicotine polacrilex Gum, Chewing; Buccal Glaxosmithkline Labeling Revision Nicorette (Mint) nicotine polacrilex Gum, Chewing; Buccal Glaxosmithkline Labeling Revision Samsca tolvaptan Tablet; Oral Otsuka America Pharm Labeling Revision Vaprisol conivaptan hydrochloride Injectable; Iv (Infusion) Astellas Labeling Revision Vaprisol In 5% Dextrose In Plastic Container conivaptan hydrochloride Injectable; Iv (Infusion) Astellas Labeling Revision   January 31, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Abacavir Sulfate; Lamivudine abacavir sulfate; lamivudine Tablet; Oral Cipla Ltd Tentative Approval Abacavir Sulfate; Lamivudine abacavir sulfate; lamivudine Tablet; Oral Mylan Labs Tentative Approval Gleevec imatinib mesylate Tablet; Oral Novartis Accelerated Approval Gralise gabapentin Tablet; Oral Depomed Inc Labeling Revision Kalydeco ivacaftor Tablet; Oral Vertex Pharms Approval Levetiracetam levetiracetam Injectable; Iv (Infusion) Pharmaforce Approval Vyvanse lisdexamfetamine dimesylate Capsule; Oral Shire Development Efficacy Supplement with Clinical Data to Support   January 30, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Bupivacaine Hydrochloride bupivacaine hydrochloride Injectable; Injection Hospira Labeling Revision Bupivacaine Hydrochloride W/Epinephrine bupivacaine hydrochloride; epinephrine bitartrate Injectable; Injection Hospira Labeling Revision Campral acamprosate calcium Tablet, Delayed Release; Oral Forest Labs Labeling Revision Cytarabine cytarabine Injectable; Injection Onco Therapies Ltd Approval Erivedge vismodegib Capsule; Oral Genentech Approval Levemir insulin detemir recombinant Injectable; Subcutaneous Novo Nordisk Inc Labeling Revision Linagliptin; Metformin linagliptin; metformin Tablet; Oral Boehringer Ingelheim Approval Marcaine bupivacaine hydrochloride Injectable; Spinal Hospira Labeling Revision Marcaine Hydrochloride bupivacaine hydrochloride Injectable; Injection Hospira Labeling Revision Marcaine Hydrochloride Preservative Free bupivacaine hydrochloride Injectable; Injection Hospira Labeling Revision Marcaine Hydrochloride W/ Epinephrine bupivacaine hydrochloride; epinephrine bitartrate Injectable; Injection Hospira Labeling Revision Marcaine Hydrochloride W/ Epinephrine Preservative Free bupivacaine hydrochloride; epinephrine bitartrate Injectable; Injection Hospira Labeling Revision Olanzapine olanzapine Tablet, Orally Disintegrating; Oral Barr Labs Inc Approval January 27, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Bydureon exenatide Injectable; Suspension; Extended Release Amylin Approval Inlyta axitinib Tablet; Oral Pfizer Approval   January 26, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Doribax doripenem Injectable; Iv (Infusion) Janssen Pharms Labeling Revision Droxia hydroxyurea Capsule; Oral Bristol Myers Squibb Labeling Revision Hydrea hydroxyurea Capsule; Oral Bristol Myers Squibb Labeling Revision Lunesta eszopiclone Tablet; Oral Sunovion Pharms Inc Labeling Revision Tekturna aliskiren hemifumarate Tablet; Oral Novartis Labeling Revision Tekturna Hct aliskiren hemifumarate; hydrochlorothiazide Tablet; Oral Novartis Labeling Revision Valturna aliskiren hemifumarate; valsartan Tablet; Oral Novartis Labeling Revision Zonegran zonisamide Capsule; Oral Eisai Inc Labeling Revision Zyrtec Allergy cetirizine hydrochloride Tablet; Oral Mcneil Consumer Labeling Revision Zyrtec Hives Relief cetirizine hydrochloride Tablet; Oral Mcneil Consumer Labeling Revision   January 25, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Amturnide aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide Tablet; Oral Novartis Labeling Revision Hydrocodone Bitartrate and Acetaminophen acetaminophen; hydrocodone bitartrate Solution; Oral Vistapharm Approval Lactulose lactulose Solution; Oral, Rectal Fresenius Kabi Approval Lactulose lactulose Solution; Oral Fresenius Kabi Approval Tekamlo aliskiren hemifumarate; amlodipine besylate Tablet; Oral Novartis Labeling Revision   January 24, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Nevirapine nevirapine Tablet; Oral Mylan Pharms Inc Tentative Approval Vidaza azacitidine Injectable; Iv-Sc Celgene Labeling Revision Vytorin ezetimibe; simvastatin Tablet; Oral Msd Intl Efficacy Supplement with Clinical Data to Support Zetia ezetimibe Tablet; Oral Msp Singapore Efficacy Supplement with Clinical Data to Support   January 23, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Lupron leuprolide acetate Injectable; Injection Abbott Labs Labeling Revision Lupron Depot leuprolide acetate Injectable; Injection Abbott Labs Labeling Revision Lupron Depot leuprolide acetate Injectable; Injection Abbott Labs Labeling Revision Mavik trandolapril Tablet; Oral Abbott Labeling Revision Morphine Sulfate morphine sulfate Solution; Oral Roxane Labeling Revision Morphine Sulfate morphine sulfate Tablet; Oral Roxane Labeling Revision Morphine Sulfate morphine sulfate Tablet; Oral Roxane Labeling Revision Tarka trandolapril; verapamil hydrochloride Tablet, Extended Release; Oral Abbott Labeling Revision Velcade bortezomib Injectable; Intravenous Millennium Pharms Efficacy (MarkIV)   January 20, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Amoxicillin and Clavulanate Potassium amoxicillin; clavulanate potassium Tablet; Oral Aurobindo Pharma Ltd Approval Amoxicillin and Clavulanate Potassium amoxicillin; clavulanate potassium Tablet; Oral Aurobindo Pharma Ltd Approval Astelin azelastine hydrochloride Spray, Metered; Nasal Meda Pharms Labeling Revision Chantix varenicline tartrate Tablet; Oral Pfizer Inc Labeling Revision Evoclin clindamycin phosphate Aerosol, Foam; Topical Stiefel Labs Inc Labeling Revision Nexium esomeprazole magnesium Capsule, Delayed Rel Pellets; Oral Astrazeneca Labeling Revision Nexium esomeprazole magnesium For Suspension, Delayed Release; Oral Astrazeneca Labeling Revision Nexium esomeprazole magnesium For Suspension, Delayed Release; Oral Astrazeneca Labeling Revision Nexium Iv esomeprazole sodium Injectable; Intravenous Astrazeneca Labeling Revision Prilosec omeprazole Capsule, Delayed Rel Pellets; Oral Astrazeneca Labeling Revision Prilosec omeprazole magnesium For Suspension, Delayed Release; Oral Astrazeneca Labeling Revision Sodium Chloride 0.9% sodium chloride Injectable; Injection Hikma (Maple) Approval Vimovo esomeprazole magnesium; naproxen Tablet, Delayed Release; Oral Astrazeneca Lp Labeling Revision Xenical orlistat Capsule; Oral Hoffmann La Roche Labeling Revision Zetonna ciclesonide Aerosol; Nasal Nycomed Gmbh Approval January 19, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Armodafinil armodafinil Tablet; Oral Mylan Pharms Inc Approval Efavirenz efavirenz Capsule; Oral Micro Labs Ltd Tentative Approval Lotensin benazepril hydrochloride Tablet; Oral Novartis Labeling Revision Lotensin Hct benazepril hydrochloride; hydrochlorothiazide Tablet; Oral Novartis Labeling Revision Lotrel amlodipine besylate; benazepril hydrochloride Capsule; Oral Novartis Labeling Revision Metoprolol Tartrate and Hydrochlorothiazide hydrochlorothiazide; metoprolol tartrate Tablet; Oral Sun Pharm Inds Approval Micardis telmisartan Tablet; Oral Boehringer Ingelheim Labeling Revision Micardis Hct hydrochlorothiazide; telmisartan Tablet; Oral Boehringer Ingelheim Labeling Revision Teveten eprosartan mesylate Tablet; Oral Abbott Labeling Revision Teveten Hct eprosartan mesylate; hydrochlorothiazide Tablet; Oral Abbott Labeling Revision Tribenzor amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil Tablet; Oral Daiichi Sankyo Labeling Revision Uniretic hydrochlorothiazide; moexipril hydrochloride Tablet; Oral Ucb Inc Labeling Revision Univasc moexipril hydrochloride Tablet; Oral Ucb Inc Labeling Revision   January 18, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Accupril quinapril hydrochloride Tablet; Oral Pfizer Pharms Labeling Revision Accuretic hydrochlorothiazide; quinapril hydrochloride Tablet; Oral Pfizer Pharms Labeling Revision Altace ramipril Tablet; Oral King Pharms Labeling Revision Diovan valsartan Tablet; Oral Novartis Labeling Revision Diovan Hct hydrochlorothiazide; valsartan Tablet; Oral Novartis Labeling Revision Escitalopram Oxalate escitalopram oxalate Solution; Oral Amneal Pharms Tentative Approval Micardis telmisartan Tablet; Oral Boehringer Ingelheim Labeling Revision Micardis Hct hydrochlorothiazide; telmisartan Tablet; Oral Boehringer Ingelheim Labeling Revision Twynsta amlodipine besylate; telmisartan Tablet; Oral Boehringer Ingelheim Approval   January 17, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Alfuzosin Hydrochloride alfuzosin hydrochloride Tablet, Extended Release; Oral Invagen Pharms Approval Pradaxa dabigatran etexilate mesylate Capsule; Oral Boehringer Ingelheim Labeling Revision Vancocin Hydrochloride In Plastic Container vancomycin hydrochloride Injectable; Injection Baxter Hlthcare Labeling Revision Vesicare solifenacin succinate Tablet; Oral Astellas Labeling Revision Voraxaze glucarpidase Injectable; Injection Btg International Inc Approval   January 13, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Adcetris brentuximab vedotin Injectable; Injection Seattle Genetics Labeling Revision Cefazolin and Dextrose cefazolin sodium Injectable; Injection B Braun General Efficacy (MarkIV) Ceftriaxone and Dextrose In Duplex Container ceftriaxone sodium Injectable; Injection B Braun Labeling Revision Enablex darifenacin hydrobromide Tablet, Extended Release; Oral Warner Chilcott Llc Labeling Revision Naftin naftifine hydrochloride Cream; Topical Merz Pharms General Efficacy (MarkIV) Nuvigil armodafinil Tablet; Oral Cephalon Labeling Revision Provigil modafinil Tablet; Oral Cephalon Labeling Revision Synercid quinupristin; dalfopristin Injectable; Injection King Pharms Labeling Revision Synercid dalfopristin; quinupristin Injectable; Iv (Infusion) King Pharms Labeling Revision   January 12, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Eszopiclone eszopiclone Tablet; Oral Sun Pharma Global Tentative Approval Oxycodone Hydrochloride oxycodone hydrochloride Solution; Oral Vistapharm Approval Periochip chlorhexidine gluconate Tablet; Dental Dexcel Pharma Labeling Revision Votrient pazopanib hydrochloride Tablet; Oral Glaxosmithkline Efficacy Supplement with Clinical Data to Support January 11, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Docetaxel docetaxel Injectable; Injection Apotex Inc Approval Irbesartan irbesartan Tablet; Oral Apotex Inc Tentative Approval Synarel nafarelin acetate Spray, Metered; Nasal Gd Searle Llc Labeling Revision   January 9, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Fazaclo Odt clozapine Tablet, Orally Disintegrating; Oral Azur Pharma Intl Labeling Revision Irbesartan and Hydrochlorothiazide irbesartan and hydrochlorothiazide Tablet; Oral Alembic Ltd Tentative Approval   January 6, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Sodium Chloride sodium chloride Injectable; Injection Medefil Inc Approval Targretin bexarotene Capsule; Oral Eisai Inc Labeling Revision   January 5, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Argatroban argatroban Injectable; Injection Hikma Farmaceutica Approval Morphine Sulfate morphine sulfate Solution; Oral Vistapharm Approval Parlodel bromocriptine mesylate Capsule; Oral Novartis Labeling Revision Parlodel bromocriptine mesylate Tablet; Oral Novartis Labeling Revision   January 4, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Subsys fentanyl Spray, Metered; Sublingual Insys Therap Approval January 3, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Symlin pramlintide acetate Injectable; Subcutaneous Amylin Labeling Revision Welchol colesevelam hydrochloride Tablet; Oral Daiichi Sankyo Labeling Revision Welchol colesevelam hydrochloride For Suspension; Oral Daiichi Sankyo Labeling Revision   December 30, 2011 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Nabumetone nabumetone Tablet; Oral Apotex Inc Approval Oxycodone Hydrochloride oxycodone hydrochloride Tablet; Oral Alvogen Approval Sodium Phosphate, Dibasic Anhydrous; Sodium Phosphate, Monobasic, Monohydrate sodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate Tablet; Oral Novel Labs Inc Approval Toviaz fesoterodine fumarate Tablet, Extended Release; Oral Pfizer Labeling Revision Tramadol Hydrochloride tramadol hydrochloride Tablet, Extended Release; Oral Sun Pharma Global Approval Verapamil Hydrochloride verapamil hydrochloride Tablet, Extended Release; Oral Sun Pharm Inds Ltd Approval   December 29, 2011 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Platinol cisplatin Injectable; Injection Corden Pharma Labeling Revision Platinol-Aq cisplatin Injectable; Injection Corden Pharma Labeling Revision   December 28, 2011 Abstral fentanyl citrate Tablet; Sublingual Prostrakan Inc Approval Actiq fentanyl citrate Troche/Lozenge; Transmucosal Cephalon Approval Eloxatin oxaliplatin Injectable; Iv (Infusion) Sanofi Aventis Us Labeling Revision Eloxatin oxaliplatin Injectable; Iv (Infusion) Sanofi Aventis Us Labeling Revision Fentora fentanyl citrate Tablet; Buccal Cephalon Approval Lazanda fentanyl citrate Spray, Metered; Nasal Archimedes Approval Onsolis fentanyl citrate Film; Buccal Meda Pharms Approval Ortho Evra ethinyl estradiol; norelgestromin Film, Extended Release; Transdermal Janssen Pharms Labeling Revision   December 27, 2011 Remeron mirtazapine Tablet; Oral Organon Usa Inc Labeling Revision   December 23, 2011 Femara letrozole Tablet; Oral Novartis Pharms Approval Fenofibrate fenofibrate Tablet; Oral Lupin Ltd Approval Heparin Lock Flush heparin sodium Injectable; Injection Hospira Labeling Revision Heparin Lock Flush In Plastic Container heparin sodium Injectable; Injection Hospira Labeling Revision Heparin Sodium heparin sodium Injectable; Injection App Pharms Labeling Revision Heparin Sodium heparin sodium Injectable; Injection Baxter Hlthcare Labeling Revision Heparin Sodium heparin sodium Injectable; Injection App Pharms Labeling Revision Heparin Sodium 1,000 Units In Sodium Chloride 0.9% In Plastic Container heparin sodium Injectable; Injection Hospira Labeling Revision Heparin Sodium 1,000 Units In Sodium Chloride 0.9% In Plastic Container heparin sodium Injectable; Injection B Braun Labeling Revision Heparin Sodium 10,000 Units In Dextrose 5% In Plastic Container heparin sodium Injectable; Injection Hospira Labeling Revision Heparin Sodium 10,000 Units In Sodium Chloride 0.45% heparin sodium Injectable; Injection Hospira Labeling Revision Heparin Sodium 10,000 Units In Sodium Chloride 0.9% heparin sodium Injectable; Injection Hospira Labeling Revision Heparin Sodium 12,500 Units In Dextrose 5% In Plastic Container heparin sodium Injectable; Injection Hospira Labeling Revision Heparin Sodium 12,500 Units In Sodium Chloride 0.45% In Plastic Container heparin sodium Injectable; Injection Hospira Labeling Revision Heparin Sodium 12,500 Units In Sodium Chloride 0.9% heparin sodium Injectable; Injection Hospira Labeling Revision Heparin Sodium 2,000 Units In Sodium Chloride 0.9% In Plastic Container heparin sodium Injectable; Injection Hospira Labeling Revision Heparin Sodium 20,000 Units In Dextrose 5% In Plastic Container heparin sodium Injectable; Injection Hospira Labeling Revision Heparin Sodium 20,000 Units In Dextrose 5% In Plastic Container heparin sodium Injectable; Injection B Braun Labeling Revision Heparin Sodium 25,000 Units In Dextrose 5% In Plastic Container heparin sodium Injectable; Injection Hospira Labeling Revision Heparin Sodium 25,000 Units In Dextrose 5% In Plastic Container heparin sodium Injectable; Injection Hospira Labeling Revision Heparin Sodium 25,000 Units In Dextrose 5% In Plastic Container heparin sodium Injectable; Injection B Braun Labeling Revision Heparin Sodium 25,000 Units In Sodium Chloride 0.45% In Plastic Container heparin sodium Injectable; Injection Hospira Labeling Revision Heparin Sodium 25,000 Units In Sodium Chloride 0.9% In Plastic Container heparin sodium Injectable; Injection Hospira Labeling Revision Heparin Sodium 5,000 Units In Sodium Chloride 0.45% heparin sodium Injectable; Injection Hospira Labeling Revision Heparin Sodium 5,000 Units In Sodium Chloride 0.9% heparin sodium Injectable; Injection Hospira Labeling Revision Heparin Sodium In Plastic Container heparin sodium Injectable; Injection App Pharms Labeling Revision Heparin Sodium Preservative Free heparin sodium Injectable; Injection Hospira Labeling Revision Heparin Sodium Preservative Free heparin sodium Injectable; Injection App Pharms Labeling Revision Ibuprofen ibuprofen Capsule; Oral Amneal Pharms Approval Isentress raltegravir Tablet, Chewable; Oral Merck Sharp Dohme Approval Panheprin heparin sodium Injectable; Injection Hospira Labeling Revision Tenofovir Disoproxil Fumarate tenofovir disoproxil fumarate Tablet; Oral Teva Pharms Tentative Approval Tylenol (Caplet) acetaminophen Tablet, Extended Release; Oral Mcneil Cons Labeling Revision Tylenol (Geltab) acetaminophen Tablet, Extended Release; Oral Mcneil Cons Labeling Revision Tyzeka telbivudine Tablet; Oral Novartis Labeling Revision Tyzeka telbivudine Solution; Oral Novartis Labeling Revision Ursodiol ursodiol Tablet; Oral Watson Labs Inc Approval   December 22, 2011 Axiron testosterone Solution, Metered; Transdermal Eli Lilly and Co Labeling Revision Dasetta norethindrone; ethinyl estradiol Tablet; Oral Novast Labs Ltd Approval Dasetta 1/35 ethinyl estradiol; norethindrone Tablet; Oral-28 Novast Labs Ltd Approval Dasetta 7/7/7 ethinyl estradiol; norethindrone Tablet; Oral-28 Novast Labs Ltd Approval Desloratadine desloratadine Tablet; Oral Perrigo R and D Approval Emtricitabine; Tenofovir Disoproxil Fumarate emtricitabine; tenofovir disoproxil fumarate Tablet; Oral Hetero Labs Unit Iii Tentative Approval Pegintron peginterferon alfa-2b Syringe Schering Supplement Pegintron peginterferon alfa-2b Vial Schering Supplement Philith ethinyl estradiol; norethindrone Tablet; Oral-28 Novast Labs Ltd Approval Suboxone buprenorphine hydrochloride; naloxone hydrochloride Tablet; Sublingual Reckitt Benckiser Labeling Revision Subutex buprenorphine hydrochloride Tablet; Sublingual Reckitt Benckiser Labeling Revision Sylatron peginterferon alfa-2b Vial Schering Supplement December 21, 2011 Advil ibuprofen; phenylephrine hydrochloride; chlorpheniramine maleate Tablet; Oral Pfizer Cons Hlthcare Approval Ampicillin and Sulbactam ampicillin sodium; sulbactam sodium Injectable; Injection Hospira Inc Approval Ampicillin and Sulbactam ampicillin sodium; sulbactam sodium Injectable; Injection Hospira Inc Approval Ampicillin and Sulbactam ampicillin sodium; sulbactam sodium Injectable; Injection Hospira Inc Approval Duac benzoyl peroxide; clindamycin phosphate Gel; Topical Stiefel Labeling Revision Fludarabine Phosphate fludarabine phosphate Injectable; Injection Onco Therapies Ltd Approval Imipenem and Cilastatin cilastatin sodium; imipenem Injectable; Injection Acs Dobfar Approval Isentress raltegravir potassium Tablet; Oral Merck Sharp Dohme Efficacy Supplement with Clinical Data to Support Ranexa ranolazine Tablet, Extended Release; Oral Gilead Labeling Revision Revlimid lenalidomide Capsule; Oral Celgene Efficacy Supplement with Clinical Data to Support Sodium Polystyrene Sulfonate sodium polystyrene sulfonate Powder; Oral, Rectal Cedar Pharms Approval   December 20, 2011 Amoxicillin and Clavulanate Potassium amoxicillin; clavulanate potassium Suspension; Oral Aurobindo Pharma Ltd Approval Amoxicillin and Clavulanate Potassium amoxicillin; clavulanate potassium Suspension; Oral Aurobindo Pharma Ltd Approval Avastin bevacizumab Vial; Intravenous Genentech Supplement Candesartan Cilexetil candesartan cilexetil Tablet; Oral Matrix Labs Ltd Tentative Approval Danocrine danazol Capsule; Oral Sanofi Aventis Us Labeling Revision Dexmedetomidine Hydrochloride dexmedetomidine hydrochloride Injectable; Injection Caraco Tentative Approval Doxycycline doxycycline Tablet; Oral Heritage Pharms Inc Approval Edarbyclor azilsartan medoxomil; chlorthalidone Tablet; Oral Takeda Pharms Na Approval Elestat epinastine hydrochloride Solution/Drops; Ophthalmic Allergan Labeling Revision Entocort EC budesonide Capsule; Oral Astrazeneca Labeling Revision Intron A interferon alfa-2b Vial Schering Supplement Plavix clopidogrel bisulfate Tablet; Oral Sanofi Aventis Us Labeling Revision Relenza zanamivir Powder; Inhalation Glaxosmithkline Labeling Revision   December 19, 2011 Dutoprol hydrochlorothiazide; metoprolol succinate Tablet, Extended Release; Oral Astrazeneca Labeling Revision Levetiracetam levetiracetam Tablet, Extended Release; Oral Mylan Pharms Inc Approval Multaq dronedarone hydrochloride Tablet; Oral Sanofi Aventis Us Labeling Revision Sustiva efavirenz Capsule; Oral Bristol Myers Squibb Labeling Revision Sustiva efavirenz Tablet; Oral Bristol Myers Squibb Labeling Revision December 16, 2011 Ditropan (oxybutynin chloride) Tablets, Janssen Pharmaceuticals, Inc., Labeling Revision Ditropan XL (oxybutynin chloride) Extended-Release Tablets, Janssen Pharmaceuticals, Inc., Labeling Revision Epiduo (adapalene and benzoyl peroxide) Gel, Galderma Laboratories, LP, Labeling Revision Metoprolol Succinate Extended-Release Tablets, Mylan Pharmaceuticals, Inc., Approval Nexium (esomeprazole magnesium) Delayed-Release Oral Suspension, AstraZeneca, LP, Efficacy Supplement with Clinical Data to Support Taxotere (docetaxel) Injection, sanofi-aventis U.S., LLC, Labeling Revision December 15, 2011 Acetaminophen Extended-Release Tablets, Ranbaxy Laboratories Ltd., Approval Bystolic (nebivolol hydrochloride) Tablets, Forest Laboratories, Inc., Labeling Revision Capoten (captopril) Tablets, Par Pharmaceutical, Inc., Labeling Revision Dilantin-125 (phenytoin) Oral Suspension, Pfizer Inc., Labeling Revision Doxycycline Hyclate Delayed-Release Tablets, Actavis Elizabeth LLC, Approval Edarbi (azilsartan medoxomil) Tablets, Takeda Pharmaceuticals, Labeling Revision Vancomycin Hydrochloride Capsules, ViroPharma, Inc., Efficacy Supplement December 14, 2011 Anturol (oxybutynin) Gel, Antares Pharma, Inc., Approval Avapro (irbesartan) Tablets, Sanofi-Aventis, Labeling Revision Crinone (progesterone) Gel, Watson Laboratories, Inc., Labeling Revision Cytarabine Injection, Onco Therapies, Ltd., Approval Exforge (amlodipine besylate and valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision Exforge HCT (amlodipine besylate, valsartan and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision Ibandronate Sodium Tablets, Mutual Pharmaceutical, Tentative Approval Latuda (lurasidone hydrochloride) Tablets, Sunovion Pharmaceuticals, Inc., Labeling Revision Methylphenidate Hydrochloride Extended-Release Capsules, Actavis, Approval Omeprazole, Sodium Bicarbonate and Magnesium Hydroxide Tablets, Santarus, Inc.,  Labeling Revision Osmoprep (sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous) Tablets, Salix Pharmaceuticals, Inc., Labeling Revision Risperdal Consta (risperidone) Intramuscular Injection, Janssen Pharmaceuticals, Inc., Labeling Revision Visicol (sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous) Tablets, Salix Pharmaceuticals, Inc., Labeling Revision Zegerid (omeprazole and sodium bicarbonate) Oral Suspension, Santarus, Inc., Labeling Revision Zegerid (omeprazole and sodium bicarbonate) Capsules, Santarus, Inc., Labeling Revision December 13, 2011 Dexmedetomidine Hydrochloride Injection, Akorn Inc., Tentative Approval Diovan (valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision Diovan HCT (hydrochlorothiazide and valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision Klonopin (clonazepam) Orally Disintegrating Tablets, Hoffmann-La Roche, Inc., Labeling Revision Klonopin (clonazepam) Tablets, Hoffmann-La Roche, Inc., Labeling Revision Nexterone (amiodarone hydrochloride) Injection, Baxter Healthcare Corp., Labeling Revision December 12, 2011 Opana (oxymorphone hydrochloride) Extended-Release Tablets, Endo Pharmaceuticals Inc., Approval Ovide (malathion) Lotion, Taro Pharmaceutical, Labeling Revision Protonix IV (pantoprazole sodium) I.V. Injection, Wyeth Pharmaceuticals Inc., Labeling Revision December 9, 2011 Atazanavir Sulfate Capsules, Teva Pharmaceuticals, Tentative Approval  Children’s Motrin (ibuprofen) Oral Suspension, McNeil Consumer Healthcare, Labeling Revision Clonidine Hydrochloride Tablets, Alembic, Ltd., Approval Crinone (progesterone) Gel, Watson Laboratories, Inc., Labeling Revision Duloxetine Hydrochloride Delayed-Release Capsules, Lupin, Ltd., Tentative Approval  Methscopolamine Bromide Tablets, Breckenridge Pharmaceutical, Inc., Approval Nicorette (nicotine polacrilex) Oral Lozenge, GlaxoSmithKline, Labeling Revision Norvir (ritonavir) Capsules, Abbott Laboratories, Labeling Revision Norvir (ritonavir) Oral Solution, Abbott Laboratories, Labeling Revision Norvir (ritonavir) Tablets, Abbott Laboratories, Labeling Revision Solaraze (diclofenac sodium) Gel, Fougera Pharmaceuticals, Inc., Labeling Revision Trospium Chloride Tablets, Apotex, Inc., Approval December 8, 2011 Lamivudine Tablets, Apotex, Inc., Approval December 7, 2011 Children's Motrin Oral Suspension, McNeil Consumer Product, Labeling Revision Methscopolamine Bromide Tablets, Breckenridge Pharmaceutical, Inc., Approval December 6, 2011 Nplate (romiplostim) Injection, Amgen, Inc., Supplement Promacta (eltrombopag olamine) Tablets, GlaxoSmithKline, Inc., Labeling Revision Xarelto (rivaroxaban) Tablets, Janssen Pharmaceuticals, Inc., Labeling Revision December 2, 2011 AndroGel (testosterone) Gel, Abbott Products, Inc., Labeling Revision Atorvastatin Calcium Tablets, Teva Pharmaceuticals, Tentative Approval Combivir (lamivudine and zidovudine) Tablets, GlaxoSmithKline, Labeling Revision Digoxin Oral Solution, Roxane Laboratories, Inc., Labeling Revision Hydromorphone Hydrochloride Injection, Hospira, Inc., Approval Isoptin SR (verapamil hydrochloride) Extended-Release Tablets, Pfizer, Inc., Labeling Revision Klonopin (clonazepam) Tablets, Hoffmann-La Roche, Inc., Labeling Revision Klonopin Rapidly Disintegrating (clonazepam) Orally Disintegrating Tablets, Hoffmann-La Roche, Inc., Labeling Revision Lamictal (lamotrigine) Tablets, GlaxoSmithKline, Labeling Revision Lamictal CD (lamotrigine) Chewable Tablets, GlaxoSmithKline, Labeling Revision Lamictal ODT (lamotrigine) Orally Disintegrating Tablets, GlaxoSmithKline, Labeling Revision Lamictal XR (lamotrigine) Extended-Release Tablets, GlaxoSmithKline, Labeling Revision Methylphenidate Hydrochloride Extended-Release Capsules, Actavis South Atlantic, LLC, Approval Minocycline Hydrochloride Extended-Release Tablets, Lupin Pharmaceuticals, Inc., Approval Reglan ODT (metoclopramide hydrochloride) Orally Disintegrating Tablets, Meda Pharmaceuticals, Inc., Labeling Revision Tramadol Hydrochloride Extended-Release Tablets, Sun Pharma Global, Tentative Approval Vytorin (ezetimibe and simvastatin) Tablets, MSD International, Labeling Revision Zyflo CR (zileuton) Extended-Release Tablets, Cornerstone Therapeutics, Inc., Labeling Revision Zyrtec Allergy (cetirizine hydrochloride) Orally Disintegrating Tablets, McNeil Consumer Healthcare, Labeling Revision December 1, 2011 Agrylin (anagrelide hydrochloride) Capsules, Shire Development, Inc., Labeling Revision Carboplatin Injection, Strides Inc., Approval Dilantin-125 (phenytoin) Oral Suspension, Pfizer Inc., Labeling Revision Egrifta (tesamorelin acetate) Subcutaneos Powder, EMD Serono Inc., Labeling Revision Guaifenesin Extended-Release Tablets, Perrigo R&D Co., Approval Irbesartan Tablets, MacLeods Pharmaceuticals Ltd., Tentative Approval Irbesartan and Hydrochlorothiazide Tablets, MacLeods Pharmaceuticals Ltd., Tentative Approval Levitra (vardenafil hydrochloride) Tablets, Bayer Healthcare Pharmaceuticals, Labeling Revision Myzilra (levonorgestrel and ethinyl estradiol) Tablets, Vintage Pharmaceuticals, Approval Risperidone Tablets, Prinston Pharmaceuticals Inc., Approval  Testim (testosterone) Gel, Auxilium Pharmaceuticals, Inc., Labeling Revision Zevalin (ibritumomab tiuxetan) Injection, Spectrum Pharmaceuticals, Inc., Supplement Zoledronic Acid Injection, Dr. Reddy’s Laboratories Ltd., Tentative Approval View Our Archive     Back to Top   Other News Digests… FDA - CBER | Today's Health & Pharma News | Drug Thesaurus | DMFs | Search | Site Map   © 2012 Betterchem.com