Drugs

New and Generic Drug Approvals

December 18, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Afinitor everolimus Tablet;Oral Novartis Efficacy Supplement with Clinical Data to Support
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

 

December 17, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Boniva ibandronate sodium Tablet;Oral Hoffmann La Roche Labeling Revision
Effexor Xr venlafaxine hydrochloride Capsule, Extended Release;Oral Wyeth Pharms Inc Labeling Revision
Lotrimin Ultra butenafine hydrochloride Cream;Topical Schering Plough Efficacy Supplement with Clinical Data to Support
Qnasl beclomethasone dipropionate Aerosol, Metered;Nasal Teva Branded Pharm Efficacy Supplement with Clinical Data to Support
Stribild cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate Tablet;Oral Gilead Sciences Inc Efficacy Supplement with Clinical Data to Support
Xtoro finafloxacin Suspension/Drops;Otic Alcon Res Ltd Approval

 

December 16, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Chg Scrub chlorhexidine gluconate Solution;Topical Ecolab Manufacturing Change or Addition
Cida-Stat chlorhexidine gluconate Solution;Topical Ecolab Manufacturing Change or Addition
Diastat diazepam Gel;Rectal Valeant Pharms North Labeling Revision
Diastat Acudial diazepam Gel;Rectal Valeant Pharms North Labeling Revision
Diclegis doxylamine succinate; pyridoxine hydrochloride Tablet, Delayed Release;Oral Duchesnay Labeling Revision
Primaxin cilastatin sodium; imipenem Powder;Intravenous Merck Labeling Revision
Somatuline Depot lanreotide acetate Injectable;Subcutaneous Ipsen Pharma Supplement
Wellbutrin bupropion hydrochloride Tablet;Oral Glaxosmithkline Labeling Revision
Wellbutrin Sr bupropion hydrochloride Tablet, Extended Release;Oral Glaxosmithkline Labeling Revision

 

December 15, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Abilify aripiprazole Tablet;Oral Otsuka Manufacturing Change or Addition
Argatroban argatroban Injectable;Injection Teva Pharms Usa Inc Approval
Brevital Sodium methohexital sodium Injectable;Injection Par Sterile Products Manufacturing Change or Addition
Cyklokapron tranexamic acid Injectable;Injection Pharmacia and Upjohn Manufacturing Change or Addition
Egrifta tesamorelin acetate Powder;Subcutaneous Theratechnologies Manufacturing Change or Addition
Ellence epirubicin hydrochloride Injectable;Injection Pfizer Inc Labeling Revision
Exparel bupivacaine Injectable, Liposomal;Injection Pacira Pharms Inc Manufacturing Change or Addition
Firmagon degarelix acetate Powder;Subcutaneous Ferring Manufacturing Change or Addition
Intralipid 10% soybean oil Injectable;Injection Fresenius Manufacturing Change or Addition
Jakafi ruxolitinib phosphate Tablet;Oral Incyte Corp Labeling Revision
Kerydin tavaborole Solution;Topical Anacor Pharms Inc Manufacturing Change or Addition
Marcaine Hydrochloride bupivacaine hydrochloride Injectable;Injection Hospira Manufacturing Change or Addition
Marcaine Hydrochloride Preservative Free bupivacaine hydrochloride Injectable;Injection Hospira Manufacturing Change or Addition
Marcaine Hydrochloride W/ Epinephrine bupivacaine hydrochloride; epinephrine bitartrate Injectable;Injection Hospira Manufacturing Change or Addition
Marcaine Hydrochloride W/ Epinephrine Preservative Free bupivacaine hydrochloride; epinephrine bitartrate Injectable;Injection Hospira Manufacturing Change or Addition
Signifor Lar pasireotide Suspension; Injectable, Intramuscular Novartis Pharms Corp Approval
Tamiflu oseltamivir phosphate Capsule;Oral Roche Manufacturing Change or Addition
Today nonoxynol-9 Sponge;Vaginal Mayer Labs Inc Manufacturing Change or Addition
Xopenex levalbuterol hydrochloride Solution;Inhalation Oak Pharms Inc Manufacturing Change or Addition

 

December 12, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Abilify aripiprazole Tablet;Oral Otsuka Efficacy Supplement with Clinical Data to Support
Abilify aripiprazole Solution;Oral Otsuka Efficacy Supplement with Clinical Data to Support
Abilify aripiprazole Tablet, Orally Disintegrating;Oral Otsuka Efficacy Supplement with Clinical Data to Support
Abilify aripiprazole Injectable;Intramuscular Otsuka Efficacy Supplement with Clinical Data to Support
Cyramza ramucirumab Injectable;Injection Eli Lilly and Co Labeling Revision
Ellence epirubicin hydrochloride Injectable;Injection Pfizer Inc Labeling Revision
Hetlioz tasimelteon Capsule;Oral Vanda Pharms Inc Labeling Revision
Lotensin benazepril hydrochloride Tablet;Oral Us Pharms Holdings I Labeling Revision
Lotensin Hct benazepril hydrochloride; hydrochlorothiazide Tablet;Oral Us Pharms Holdings I Labeling Revision
Micardis telmisartan Tablet;Oral Boehringer Ingelheim Labeling Revision
Micardis Hct hydrochlorothiazide; telmisartan Tablet;Oral Boehringer Ingelheim Labeling Revision
Pulmozyme dornase alfa Vial Genentech Efficacy Supplement with Clinical Data to Support
Twynsta amlodipine besylate; telmisartan Tablet;Oral Boehringer Ingelheim Labeling Revision
Tylenol acetaminophen Tablet, Extended Release;Oral Mcneil Cons Labeling Revision

 

December 11, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Abraxane paclitaxel For Suspension;Iv (Infusion) Abraxis Bioscience Labeling Revision
Bloxiverz neostigmine methylsulfate Solution;Intravenous Eclat Pharms Llc Labeling Revision
Bromday bromfenac sodium Solution/Drops;Ophthalmic Bausch and Lomb Inc Manufacturing Change or Addition
Children's Motrin ibuprofen Suspension;Oral Mcneil Labeling Revision
Kalydeco ivacaftor Tablet;Oral Vertex Pharms Manufacturing Change or Addition
Linzess linaclotide Capsule;Oral Forest Labs Inc Manufacturing Change or Addition
Ovidrel choriogonadotropin alfa Injectable;Injection Emd Serono Manufacturing Change or Addition
Ovidrel choriogonadotropin alfa Injectable;Subcutaneous Emd Serono Manufacturing Change or Addition
Suboxone buprenorphine hydrochloride; naloxone hydrochloride Tablet;Sublingual Reckitt Benckiser Labeling Revision
Subutex buprenorphine hydrochloride Tablet;Sublingual Reckitt Benckiser Labeling Revision
Twynsta amlodipine besylate; telmisartan Tablet;Oral Boehringer Ingelheim Manufacturing Change or Addition
Varithena polidocanol Solution;Intravenous Provensis Manufacturing Change or Addition
Xibrom bromfenac sodium Solution/Drops;Ophthalmic Bausch and Lomb Inc Manufacturing Change or Addition
Zubsolv buprenorphine hydrochloride; naloxone hydrochloride Tablet;Sublingual Orexo Ab Manufacturing Change or Addition

 

December 10, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Advair Hfa fluticasone propionate; salmeterol xinafoate Aerosol, Metered;Inhalation Glaxo Grp Ltd Labeling Revision
Flovent Hfa fluticasone propionate Aerosol, Metered;Inhalation Glaxo Grp Ltd Labeling Revision
Geodon ziprasidone hydrochloride Capsule;Oral Pfizer Labeling Revision
Geodon ziprasidone mesylate Injectable;Intramuscular Pfizer Labeling Revision
Geodon ziprasidone hydrochloride Suspension;Oral Pfizer Inc Labeling Revision
Zoledronic Acid zoledronic acid Injectable;Iv (Infusion) Acs Dobfar Info Sa Labeling Revision

 

December 9, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Belviq lorcaserin hydrochloride Tablet;Oral Eisai Inc Labeling Revision
Extraneal icodextrin Solution;Intraperitoneal Baxter Hlthcare Labeling Revision
Onfi clobazam Tablet;Oral Lundbeck Llc Labeling Revision
Onfi clobazam Suspension;Oral Lundbeck Llc Labeling Revision

 

December 8, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Delflex W/ Dextrose 1.5% In Plastic Container calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate Solution;Intraperitoneal Fresenius Medcl Manufacturing Change or Addition
Delflex W/ Dextrose 1.5% Low Magnesium In Plastic Container calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate Solution;Intraperitoneal Fresenius Medcl Manufacturing Change or Addition
Delflex W/ Dextrose 2.5% In Plastic Container calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate Solution;Intraperitoneal Fresenius Medcl Manufacturing Change or Addition
Delflex W/ Dextrose 2.5% Low Magnesium In Plastic Container calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate Solution;Intraperitoneal Fresenius Medcl Manufacturing Change or Addition
Delflex W/ Dextrose 4.25% In Plastic Container calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate Solution;Intraperitoneal Fresenius Medcl Manufacturing Change or Addition
Delflex W/ Dextrose 4.25% Low Magnesium In Plastic Container calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate Solution;Intraperitoneal Fresenius Medcl Manufacturing Change or Addition
Mirena levonorgestrel Intrauterine Device;Intrauterine Bayer Hlthcare Manufacturing Change or Addition

 

December 5, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Abilify Maintena Kit aripiprazole For Suspension, Extended Release;Intramuscular Otsuka Pharm Co Ltd Efficacy Supplement with Clinical Data to Support
Adriamycin Pfs doxorubicin hydrochloride Injectable;Injection Pharmacia and Upjohn Manufacturing Change or Addition
Benzaclin benzoyl peroxide; clindamycin phosphate Gel;Topical Valeant Bermuda Manufacturing Change or Addition
Benzamycin benzoyl peroxide; erythromycin Gel;Topical Valeant Intl Manufacturing Change or Addition
Cardiogen-82 rubidium chloride rb-82 Injectable;Injection Bracco Manufacturing Change or Addition
Exparel bupivacaine Injectable, Liposomal;Injection Pacira Pharms Inc Labeling Revision
Heparin Sodium heparin sodium Injectable;Injection Pfizer Manufacturing Change or Addition
Heparin Sodium Preservative Free heparin sodium Injectable;Injection Pfizer Manufacturing Change or Addition
Klaron sulfacetamide sodium Lotion;Topical Valeant Bermuda Manufacturing Change or Addition
Minastrin 24 Fe ethinyl estradiol; norethindrone acetate Tablet, Chewable;Oral Warner Chilcott Llc Labeling Revision
Noritate metronidazole Cream;Topical Valeant Bermuda Manufacturing Change or Addition
Prolia denosumab Injectable; Subcutaneous Amgen Efficacy Supplement with Clinical Data to Support
Tricor fenofibrate Tablet;Oral Abbott Labeling Revision
Xgeva denosumab Injectable; Subcutaneous Amgen Efficacy Supplement with Clinical Data to Support

 

December 4, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Acuvail ketorolac tromethamine Solution/Drops;Ophthalmic Allergan Labeling Revision
Idamycin idarubicin hydrochloride Injectable;Injection Pharmacia and Upjohn Labeling Revision
Idamycin Pfs idarubicin hydrochloride Injectable;Injection Pharmacia and Upjohn Labeling Revision
Jakafi ruxolitinib phosphate Tablet;Oral Incyte Corp Efficacy Supplement with Clinical Data to Support
Lastacaft alcaftadine Solution/Drops;Ophthalmic Allergan Labeling Revision
Mozobil plerixafor Solution;Subcutaneous Genzyme Labeling Revision
Pamidronate Disodium pamidronate disodium Injectable;Injection Eurohlth Intl Labeling Revision
Vizamyl flutemetamol f-18 Injectable;Intravenous Ge Healthcare Labeling Revision

 

December 3, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Blincyto blinatumomab Injectable;Injection Amgen Approval
Iquix levofloxacin Solution/Drops;Ophthalmic Santen Labeling Revision
Premarin estrogens, conjugated Tablet;Oral Wyeth Pharms Inc Labeling Revision
Quixin levofloxacin Solution/Drops;Ophthalmic Santen Labeling Revision
Survanta beractant Suspension;Intratracheal Abbvie Manufacturing Change or Addition
Tecfidera dimethyl fumarate Capsule, Delayed Release;Oral Biogen Idec Inc Efficacy Supplement with Clinical Data to Support
Tecfidera dimethyl fumarate Capsule, Delayed Release;Oral Biogen Idec Inc Labeling Revision
Vibativ telavancin hydrochloride Powder;Iv (Infusion) Theravance Biopharma Labeling Revision

 

December 2, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Acephen acetaminophen Suppository;Rectal G and W Labs Manufacturing Change or Addition
Actonel risedronate sodium Tablet;Oral Warner Chilcott Llc Manufacturing Change or Addition
Allegra Allergy fexofenadine hydrochloride Tablet;Oral Sanofi Aventis Us Manufacturing Change or Addition
Allegra Hives fexofenadine hydrochloride Tablet;Oral Sanofi Aventis Us Manufacturing Change or Addition
Bloxiverz neostigmine methylsulfate Solution;Intravenous Eclat Pharms Llc Manufacturing Change or Addition
Cardene nicardipine hydrochloride Injectable;Injection Chiesi Usa Inc Manufacturing Change or Addition
Cardene In 0.83% Sodium Chloride In Plastic Container nicardipine hydrochloride Injectable;Intravenous Chiesi Usa Inc Manufacturing Change or Addition
Cardene In 0.86% Sodium Chloride In Plastic Container nicardipine hydrochloride Injectable;Intravenous Chiesi Usa Inc Manufacturing Change or Addition
Cardene In 4.8% Dextrose In Plastic Container nicardipine hydrochloride Injectable;Intravenous Chiesi Usa Inc Manufacturing Change or Addition
Cardene In 5.0% Dextrose In Plastic Container nicardipine hydrochloride Injectable;Intravenous Chiesi Usa Inc Manufacturing Change or Addition
Children's Allegra Allergy fexofenadine hydrochloride Tablet;Oral Sanofi Aventis Us Manufacturing Change or Addition
Children's Allegra Hives fexofenadine hydrochloride Tablet;Oral Sanofi Aventis Us Manufacturing Change or Addition
Coumadin warfarin sodium Injectable;Injection Bristol Myers Squibb Manufacturing Change or Addition
Coumadin warfarin sodium Tablet;Oral Bristol Myers Squibb Manufacturing Change or Addition
Delzicol mesalamine Capsule, Delayed Release;Oral Warner Chilcott Llc Manufacturing Change or Addition
Docetaxel docetaxel Injectable;Injection Pfizer Labs Manufacturing Change or Addition
Dutoprol hydrochlorothiazide; metoprolol succinate Tablet, Extended Release;Oral Covis Pharma Sarl Manufacturing Change or Addition
Nexavar sorafenib tosylate Tablet;Oral Bayer Hlthcare Manufacturing Change or Addition
Procysbi cysteamine bitartrate Capsule, Delayed Release;Oral Raptor Inc Manufacturing Change or Addition
Sucraid sacrosidase Solution;Oral Qol Medcl Manufacturing Change or Addition
Symbicort budesonide; formoterol fumarate dihydrate Aerosol, Metered;Inhalation Astrazeneca Manufacturing Change or Addition
Targretin bexarotene Capsule;Oral Valeant Luxembourg Manufacturing Change or Addition
Tobramycin tobramycin Solution;Inhalation, Nebulizer Pulmoflow Inc Approval
Vpriv velaglucerase alfa Injectable;Iv (Infusion) Shire Human Genetic Manufacturing Change or Addition
Vpriv velaglucerase alfa Powder;Iv (Infusion) Shire Human Genetic Manufacturing Change or Addition

 

December 1, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Bimatoprost bimatoprost Solution;Ophthalmic Apotex Inc Approval
Brisdelle paroxetine mesylate Capsule;Oral Noven Therap Labeling Revision
Sarafem fluoxetine hydrochloride Tablet;Oral Warner Chilcott Llc Labeling Revision

 

November 26, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Cubicin daptomycin Injectable;Iv (Infusion) Cubist Labeling Revision
Mytelase ambenonium chloride Tablet;Oral Sanofi Aventis Us Labeling Revision
Renagel sevelamer hydrochloride Tablet;Oral Genzyme Labeling Revision
Renvela sevelamer carbonate Tablet;Oral Genzyme Labeling Revision
Renvela sevelamer carbonate For Suspension;Oral Genzyme Labeling Revision
Singulair montelukast sodium Tablet;Oral Merck Labeling Revision
Singulair montelukast sodium Tablet, Chewable;Oral Merck Labeling Revision
Singulair montelukast sodium Granule;Oral Merck Labeling Revision
Tamiflu oseltamivir phosphate Capsule;Oral Roche Labeling Revision
Tamiflu oseltamivir phosphate For Suspension;Oral Roche Labeling Revision

 

November 25, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Amoxil amoxicillin For Suspension;Oral Dr Reddys Labs Inc Labeling Revision
Bosulif bosutinib monohydrate Tablet;Oral Wyeth Pharms Inc Labeling Revision
Bupropion Hydrochloride bupropion hydrochloride Tablet, Extended Release;Oral Sandoz Labeling Revision
Bupropion Hydrochloride bupropion hydrochloride Tablet;Oral Apotex Inc Labeling Revision
Bupropion Hydrochloride bupropion hydrochloride Tablet, Extended Release;Oral Sun Pharma Global Labeling Revision
Bupropion Hydrochloride bupropion hydrochloride Tablet, Extended Release;Oral Actavis Labs Fl Inc Labeling Revision
Bupropion Hydrochloride bupropion hydrochloride Tablet, Extended Release;Oral Mylan Labeling Revision
Bupropion Hydrochloride bupropion hydrochloride Tablet, Extended Release;Oral Anchen Pharms Labeling Revision
Bupropion Hydrochloride bupropion hydrochloride Tablet, Extended Release;Oral Zydus Pharms Usa Inc Labeling Revision
Bupropion Hydrochloride bupropion hydrochloride Tablet, Extended Release;Oral Jubilant Generics Labeling Revision
Cymbalta duloxetine hydrochloride Capsule, Delayed Rel Pellets;Oral Lilly Labeling Revision
Divalproex Sodium divalproex sodium Tablet, Extended Release;Oral Reddys Labeling Revision
Divalproex Sodium divalproex sodium Tablet, Delayed Release;Oral Aurobindo Pharma Ltd Labeling Revision
Divalproex Sodium divalproex sodium Tablet, Extended Release;Oral Aurobindo Pharma Ltd Labeling Revision
Larotid amoxicillin For Suspension;Oral Dr Reddys Labs Inc Labeling Revision
Lucentis ranibizumab Injectable; Injection Genentech Efficacy Supplement with Clinical Data to Support
Norco acetaminophen; hydrocodone bitartrate Tablet;Oral Watson Labs Labeling Revision
Priftin rifapentine Tablet;Oral Sanofi Aventis Us Efficacy Supplement with Clinical Data to Support
Topiramate topiramate Capsule;Oral Zydus Pharms Usa Inc Labeling Revision
Tussicaps chlorpheniramine polistirex; hydrocodone polistirex Capsule, Extended Release;Oral Ecr Pharma Labeling Revision
Voltaren diclofenac sodium Gel;Topical Novartis Labeling Revision
Xalatan latanoprost Solution/Drops;Ophthalmic Pharmacia and Upjohn Labeling Revision
Zelboraf vemurafenib Tablet;Oral Hoffmann La Roche Labeling Revision

 

 

 

Page Last Updated: 12/19/2014
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