Drugs

New and Generic Drug Approvals

November 20, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Aleve Pm diphenhydramine hydrochloride; naproxen sodium Tablet;Oral Bayer Hlthcare Labeling Revision
Avelox moxifloxacin hydrochloride Tablet;Oral Bayer Hlthcare Labeling Revision
Avelox In Sodium Chloride 0.8% In Plastic Container moxifloxacin hydrochloride Injectable;Iv (Infusion) Bayer Hlthcare Labeling Revision
Biltricide praziquantel Tablet;Oral Bayer Hlthcare Manufacturing Change or Addition
Carac fluorouracil Cream;Topical Valeant Bermuda Manufacturing Change or Addition
Dalvance dalbavancin hydrochloride Injectable;Iv (Infusion) Durata Theraps Intl Manufacturing Change or Addition
Depacon valproate sodium Injectable;Injection Abbvie Labeling Revision
Depakene valproic acid Capsule;Oral Abbvie Labeling Revision
Depakene valproic acid Syrup;Oral Abbvie Labeling Revision
Depakote divalproex sodium Tablet, Delayed Release;Oral Abbvie Labeling Revision
Depakote divalproex sodium Capsule, Delayed Rel Pellets;Oral Abbvie Labeling Revision
Depakote Er divalproex sodium Tablet, Extended Release;Oral Abbvie Labeling Revision
Finasteride finasteride Tablet;Oral Cipla Ltd Approval
Gliadel carmustine Implant;Intracranial Arbor Pharms Llc Labeling Revision
Hysingla Er hydrocodone bitartrate Tablet, Extended Release;Oral Purdue Pharma Approval
Isordil isosorbide dinitrate Tablet;Oral Valeant Bermuda Manufacturing Change or Addition
Jenloga clonidine hydrochloride Tablet, Extended Release;Oral Concordia Pharms Inc Efficacy Supplement with Clinical Data to Support
Kapvay clonidine hydrochloride Tablet, Extended Release;Oral Concordia Pharms Inc Efficacy Supplement with Clinical Data to Support
Locoid Lipocream hydrocortisone butyrate Cream;Topical Precision Dermat Labeling Revision
Priftin rifapentine Tablet;Oral Sanofi Aventis Us Labeling Revision
Stendra avanafil Tablet;Oral Vivus Manufacturing Change or Addition

 

November 19, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Avelox moxifloxacin hydrochloride Tablet;Oral Bayer Hlthcare Manufacturing Change or Addition
Creon pancrelipase (amylase;lipase;protease) Capsule, Delayed Release;Oral Abbvie Manufacturing Change or Addition
Drospirenone and Ethinyl Estradiol drospirenone;ethinyl estradiol Tablet;Oral Novast Labs Ltd Approval
Intuniv guanfacine hydrochloride Tablet, Extended Release;Oral Shire Efficacy Supplement with Clinical Data to Support
Jevtana Kit cabazitaxel Solution;Iv (Infusion) Sanofi Aventis Us Labeling Revision
Lioresal baclofen Injectable;Intrathecal Medtronic Neuro Labeling Revision
Tobi Podhaler tobramycin Powder;Inhalation Novartis Labeling Revision

 

November 18, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Children's Fexofenadine Hydrochloride Allergy fexofenadine hydrochloride Suspension;Oral Actavis Mid Atlantic Approval
Children's Fexofenadine Hydrochloride Hives fexofenadine hydrochloride Suspension;Oral Actavis Mid Atlantic Approval
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride fexofenadine hydrochloride; pseudoephedrine hydrochloride Tablet, Extended Release;Oral Dr Reddys Labs Ltd Approval
Fexofenadine Hydrochloride; Pseudoephedrine Hydrochloride fexofenadine hydrochloride; pseudoephedrine hydrochloride Tablet, Extended Release;Oral Dr Reddys Labs Ltd Approval
Paricalcitol paricalcitol Injectable;Injection Hikma Approval
Saphris asenapine maleate Tablet;Sublingual Forest Labs Inc Labeling Revision
Votrient pazopanib hydrochloride Tablet;Oral Glaxosmithkline Efficacy Supplement with Clinical Data to Support

 

November 17, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Cutivate fluticasone propionate Lotion;Topical Fougera Pharms Manufacturing Change or Addition
Hepatamine 8% amino acids Injectable;Injection B Braun Manufacturing Change or Addition
Nucynta tapentadol hydrochloride Solution;Oral Janssen Pharms Labeling Revision
Pegintron peginterferon alfa-2b Syringe Schering Labeling Revision
Pegintron peginterferon alfa-2b Vial Schering Labeling Revision
Sylatron peginterferon alfa-2b Vial Schering Labeling Revision
Unasyn ampicillin sodium; sulbactam sodium Injectable;Injection Pfizer Labeling Revision

 

November 16, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Choline C-11 choline c-11 Injectable;Intravenous Mcprf Manufacturing Change or Addition
Fiorinal W/Codeine aspirin; butalbital; caffeine; codeine phosphate Capsule;Oral Watson Labs Inc Manufacturing Change or Addition
Injectafer ferric carboxymaltose Injectable;Intravenous Luitpold Manufacturing Change or Addition
Morphine Sulfate morphine sulfate Solution;Intramuscular, Intravenous Bd Rx Manufacturing Change or Addition
Resectisol In Plastic Container mannitol Solution;Irrigation B Braun Manufacturing Change or Addition
Zytiga abiraterone acetate Tablet;Oral Janssen Biotech Manufacturing Change or Addition

 

November 15, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Ferric Citrate ferric citrate Tablet;Oral Keryx Biopharms Labeling Revision

 

November 14, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Androgel testosterone Gel, Metered;Transdermal Abbvie Labeling Revision
Androgel testosterone Gel;Transdermal Abbvie Labeling Revision
Avastin bevacizumab Vial; Intravenous Genentech Efficacy Supplement with Clinical Data to Support
Campath alemtuzumab Vial; Intravenous Ilex Pharmaceuticals Labeling Revision
Flovent Hfa fluticasone propionate Aerosol, Metered;Inhalation Glaxo Grp Ltd Labeling Revision
Fycompa perampanel Tablet;Oral Eisai Inc Labeling Revision
Obredon hydrococone bitartrate; guaifenesin Solution;Oral Sovereign Pharma Llc Approval
Omniscan gadodiamide Injectable;Injection Ge Healthcare Labeling Revision
Precedex dexmedetomidine hydrochloride Injectable;Injection Hospira Labeling Revision
Precedex dexmedetomidine hydrochloride Injectable;Injection Hospira Manufacturing Change or Addition
Sovaldi sofosbuvir Tablet;Oral Gilead Sciences Inc Labeling Revision
Taxotere docetaxel Injectable;Injection Sanofi Aventis Us Labeling Revision
Tecfidera dimethyl fumarate Capsule, Delayed Release;Oral Biogen Idec Inc Labeling Revision
Vyvanse lisdexamfetamine dimesylate Capsule;Oral Shire Development Labeling Revision

 

November 13, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Actemra tocilizumab Injectable; Injection Genentech Labeling Revision
Advair Diskus 100/50 fluticasone propionate; salmeterol xinafoate Powder;Inhalation Glaxo Grp Ltd Labeling Revision
Advair Diskus 250/50 fluticasone propionate; salmeterol xinafoate Powder;Inhalation Glaxo Grp Ltd Labeling Revision
Advair Diskus 500/50 fluticasone propionate; salmeterol xinafoate Powder;Inhalation Glaxo Grp Ltd Labeling Revision
Advair Hfa fluticasone propionate; salmeterol xinafoate Aerosol, Metered;Inhalation Glaxo Grp Ltd Labeling Revision
Flovent Diskus 100 fluticasone propionate Powder;Inhalation Glaxo Grp Ltd Labeling Revision
Flovent Diskus 250 fluticasone propionate Powder;Inhalation Glaxo Grp Ltd Labeling Revision
Flovent Diskus 50 fluticasone propionate Powder;Inhalation Glaxo Grp Ltd Labeling Revision
Mycobutin rifabutin Capsule;Oral Pharmacia and Upjohn Labeling Revision
Zolmitriptan zolmitriptan Tablet;Oral Sun Pharma Global Approval

 

 

Page Last Updated: 11/21/2014
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