CDER New December 23, 2014

FDA (U.S. Food and Drug Administration)

What's New on the FDA Drugs Site

December 23, 2014


New and Generic Drug Approvals

December 22, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Cordarone amiodarone hydrochloride Tablet;Oral Wyeth Pharms Inc Labeling Revision
Dextrose 10% In Plastic Container dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Dextrose 20% In Plastic Container dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Dextrose 30% In Plastic Container dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Dextrose 40% In Plastic Container dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Dextrose 5% and Potassium Chloride 0.075% In Plastic Container dextrose; potassium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Dextrose 5% and Potassium Chloride 0.15% In Plastic Container dextrose; potassium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Dextrose 5% and Potassium Chloride 0.224% In Plastic Container dextrose; potassium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Dextrose 5% and Potassium Chloride 0.3% In Plastic Container dextrose; potassium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Dextrose 5% In Plastic Container dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Dextrose 50% In Plastic Container dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Dextrose 50% In Plastic Container dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Dextrose 60% In Plastic Container dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Dextrose 60% In Plastic Container dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Dextrose 70% In Plastic Container dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Dextrose 70% In Plastic Container dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Extavia interferon beta-1b Injectable; Subcutaneous Novartis Pharms Labeling Revision
Opdivo nivolumab Injectable;Injection Bristol Myers Squibb Approval
Plasma-Lyte 56 and Dextrose 5% In Plastic Container dextrose; magnesium acetate tetrahydrate; potassium acetate; sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Potassium Chloride potassium chloride Solution; Oral Pharma-Med Inc Approval
Remodulin treprostinil Injectable;Iv (Infusion), Subcutaneous United Therap Labeling Revision
Sodium Chloride 0.45% In Plastic Container sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Sodium Chloride 0.9% In Plastic Container sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Sodium Chloride 3% In Plastic Container sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Sodium Chloride 5% In Plastic Container sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Somatuline Depot lanreotide acetate Injectable;Subcutaneous Ipsen Pharma Labeling Revision
Tykerb lapatinib ditosylate Tablet;Oral Smithkline Beecham Labeling Revision

 

December 19, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Acetazolamide Sodium acetazolamide sodium Injectable;Injection Emcure Pharms Ltd Approval
Aciphex rabeprazole sodium Tablet, Delayed Release;Oral Eisai Inc Labeling Revision
Aciphex Sprinkle rabeprazole sodium Capsule, Delayed Release;Oral Eisai Inc Labeling Revision
Camptosar irinotecan hydrochloride Injectable;Injection Pfizer Inc Labeling Revision
Clozaril clozapine Tablet;Oral Novartis Labeling Revision
Cutivate fluticasone propionate Lotion;Topical Fougera Pharms Manufacturing Change or Addition
Dexilant dexlansoprazole Capsule, Delayed Release;Oral Takeda Pharms Usa Labeling Revision
Erwinaze asparaginase erwinia chrysanthemi Injectable; Injection Eusa Pharma Usa Labeling Revision
Esomeprazole Strontium esomeprazole strontium Capsule, Delayed Release;Oral Hanmi Pharm Co Ltd Labeling Revision
Estradiol estradiol Film, Extended Release;Transdermal Mylan Technologies Approval
Ganirelix Acetate ganirelix acetate Injectable;Injection Organon Usa Inc Labeling Revision
Halaven eribulin mesylate Solution;Intravenous Eisai Inc Labeling Revision
Lynparza olaparib Capsule; Oral Astrazeneca Lp Approval
Merrem meropenem Injectable;Injection Astrazeneca 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
Prevacid lansoprazole Capsule, Delayed Rel Pellets;Oral Takeda Pharms Usa Labeling Revision
Prevacid lansoprazole Tablet, Delayed Release, Orally Disintegrating;Oral Takeda Pharms Usa Labeling Revision
Prevpac amoxicillin; clarithromycin; lansoprazole Capsule, Capsule, Delayed Rel Pellets, Tablet;Oral Takeda Pharms Usa Labeling Revision
Prilosec omeprazole Capsule, Delayed Rel Pellets;Oral Astrazeneca Labeling Revision
Prilosec omeprazole magnesium For Suspension, Delayed Release;Oral Astrazeneca Labeling Revision
Protonix pantoprazole sodium Tablet, Delayed Release;Oral Wyeth Pharms Inc Labeling Revision
Protonix pantoprazole sodium For Suspension, Delayed Release;Oral Wyeth Pharms Inc Labeling Revision
Protonix Iv pantoprazole sodium Injectable;Iv (Infusion) Wyeth Pharms Inc Labeling Revision
Rapivab peramivir Injectable;Iv (Infusion) Biocryst Pharmaceuticals Inc Approval
Simponi golimumab Injectable; Injection Centocor Ortho Biotech Inc Labeling Revision
Simponi Aria golimumab Injectable; Injection Janssen Biotech Labeling Revision
Soolantra ivermectin Cream;Topical Galderma Res and Dev Llc Approval
Sutent sunitinib malate Capsule;Oral Cppi Cv Labeling Revision
Symbyax fluoxetine hydrochloride; olanzapine Capsule;Oral Lilly Labeling Revision
Tbo-Filgrastim tbo-filgrastim Injectable; Injection Sicor Biotech Labeling Revision
Tivicay dolutegravir sodium Tablet;Oral Viiv Hlthcare Labeling Revision
Trulicity dulaglutide Injectable;Injection Eli Lilly and Co Labeling Revision
Ventolin Hfa albuterol sulfate Aerosol, Metered;Inhalation Glaxosmithkline Labeling Revision
Viekira Pak ombitasivr; paritaprevir; ritonavir; dasabuvir Tablet, Tablet;Oral Abbvie Inc Approval
Vimovo esomeprazole magnesium; naproxen Tablet, Delayed Release;Oral Horizon Pharma Labeling Revision
Xarelto rivaroxaban Tablet;Oral Janssen Pharms Labeling Revision
Zegerid omeprazole; sodium bicarbonate For Suspension;Oral Santarus Inc Labeling Revision
Zegerid omeprazole; sodium bicarbonate Capsule;Oral Santarus Inc Labeling Revision
Zerbaxa ceftolozane;tazobactam Injectable;Injection Cubist Pharms Inc Approval
Zyprexa olanzapine Tablet;Oral Lilly Labeling Revision
Zyprexa olanzapine Injectable;Intramuscular Lilly Labeling Revision
Zyprexa Relprevv olanzapine pamoate Suspension, Extended Release;Intramuscular Eli Lilly Co Labeling Revision
Zyprexa Zydis olanzapine Tablet, Orally Disintegrating;Oral Lilly Labeling Revision

 

December 18, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Afinitor everolimus Tablet;Oral Novartis Efficacy Supplement with Clinical Data to Support
Ammonia N-13 ammonia n 13 Injectable;Intravenous Wi Medcl Cyclotron Approval
Bupropion Hydrochloride bupropion hydrochloride Tablet, Extended Release;Oral Sun Pharma Global Approval
Fludeoxyglucose F18 fludeoxyglucose f-18 Injectable;Intravenous Shertech Labs Llc Approval
Lamivudine lamivudine Tablet;Oral Lupin Ltd Approval
Magnesium Sulfate magnesium sulfate Injectable;Injection Exela Pharma Scs Llc Approval
Oxycodone Hydrochloride and Acetaminophen acetaminophen; oxycodone hydrochloride Solution;Oral Vintage Pharms Approval
Topamax topiramate Tablet;Oral Janssen Pharms Labeling Revision
Topamax topiramate Capsule;Oral Janssen Pharms Labeling Revision
Topamax Sprinkle topiramate Capsule;Oral Janssen Pharms Labeling Revision

 


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