Drugs

New and Generic Drug Approvals

 

April 28, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Adapalene; Benzoyl Peroxideadapalene;benzoyl peroxideGel;TopicalGlenmark Pharms LtdTentative Approval
BicnucarmustineInjectable;InjectionEmcure Pharms LtdLabeling Revision
Cimziacertolizumab pegolInjectable; InjectionUcb IncLabeling Revision
Kadcylaado-trastuzumab emtansineVial; Single-UseGenentechLabeling Revision
LacosamidelacosamideSolution;OralAmneal PharmsApproval
LacosamidelacosamideTablet;OralActavis Labs Fl IncApproval
LacosamidelacosamideTablet;OralAlembic Pharms LtdApproval
LacosamidelacosamideTablet;OralAurobindo Pharma LtdApproval
LacosamidelacosamideTablet;OralMylan Pharms IncApproval
LacosamidelacosamideTablet;OralSun Pharma GlobalApproval
Mirceramethoxy polyethylene glycol-epoetin betaSolution; InjectionHoffman-La RocheLabeling Revision
NeulastapegfilgrastimSyringeAmgenLabeling Revision
Olmesartan Medoxomilolmesartan medoxomilTablet;OralAmneal Pharms CoTentative Approval
Plasma-Lyte 148 In Water In Plastic Containermagnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconateInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Plasma-Lyte A In Plastic Containermagnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconateInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Proair Respiclickalbuterol sulfatePowder, Metered;InhalationTeva Branded PharmEfficacy Supplement with Clinical Data to Support
Trandatelabetalol hydrochlorideTablet;OralCnty Line PharmsManufacturing Change or Addition
XalkoricrizotinibCapsule;OralPf Prism CvLabeling Revision

 

April 27, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Aranespdarbepoetin alfaVial; IntravenousAmgenLabeling Revision
Aranespdarbepoetin alfaVial; SubcutaneousAmgenLabeling Revision
Bss Pluscalcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphateSolution;IrrigationAlconSupplement
GadavistgadobutrolSolution;IntravenousBayer HlthcareEfficacy Supplement with Clinical Data to Support
Ringer's In Plastic Containercalcium chloride; potassium chloride; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision

 

April 26, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Acticlatedoxycycline hyclateTablet;OralAqua Pharms LlcLabeling Revision
Acticlate Capdoxycycline hyclateCapsule;OralAqua PharmsApproval
Oxymorphone Hydrochlorideoxymorphone hydrochlorideTablet;OralAurolife Pharma LlcApproval
Simponi AriagolimumabInjectable; InjectionJanssen BiotechLabeling Revision
Sodium Chloride 0.45% In Plastic Containersodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Sodium Chloride 0.9% In Plastic Containersodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Sodium Chloride 3% In Plastic Containersodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Sodium Chloride 5% In Plastic Containersodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
TadalafiltadalafilTablet;OralAurobindo Pharma LtdTentative Approval
Xtampza EroxycodoneCapsule, Extended Release;OralCollegium Pharms IncApproval

 

April 25, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Amlodipine Besylate and Valsartanamlodipine besylate; valsartanTablet;OralAurobindo Pharma LtdApproval
Atnaaatropine; pralidoxime chlorideInjectable;IntramuscularUs ArmyManufacturing Change or Addition
Bevespi Aerosphereglycopyrrolate;formoterol fumarateAerosol, Metered;InhalationPearl Therapeutics IncApproval
Cabometyxcabozantinib (s)-malateTablet;OralExelixis IncApproval
Doxil (Liposomal)doxorubicin hydrochlorideInjectable, Liposomal;InjectionJanssen Res and DevManufacturing Change or Addition
Duodoteatropine; pralidoxime chlorideInjectable;IntramuscularMeridian MedclManufacturing Change or Addition
Fazaclo OdtclozapineTablet, Orally Disintegrating;OralJazz Pharms IiiManufacturing Change or Addition
Fluocinolone Acetonidefluocinolone acetonideOil;TopicalLyneApproval
Fluocinolone Acetonidefluocinolone acetonideOil;TopicalLyneApproval
Fluocinolone Acetonidefluocinolone acetonideOil/Drops;OticLyneApproval
Limbitrolamitriptyline hydrochloride; chlordiazepoxideTablet;OralHeritage Pharms IncLabeling Revision
Limbitrol Dsamitriptyline hydrochloride; chlordiazepoxideTablet;OralHeritage Pharms IncLabeling Revision
Marqibo Kitvincristine sulfateInjectable, Liposomal;IntravenousTalon TherapManufacturing Change or Addition
NascobalcyanocobalaminSpray, Metered;NasalEndo Pharms IncManufacturing Change or Addition
Savaysaedoxaban tosylateTablet;OralDaiichi SankyoManufacturing Change or Addition
Trifericferric pyrophosphate citrateSolution;IntraperitonealRockwell Medical IncApproval
Wellbutrinbupropion hydrochlorideTablet;OralGlaxosmithklineLabeling Revision
Wellbutrin Srbupropion hydrochlorideTablet, Extended Release;OralGlaxosmithklineLabeling Revision

 

April 22, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Aerospan HfaflunisolideAerosol, Metered;InhalationMeda Pharms IncManufacturing Change or Addition
An-Sulfur Colloidtechnetium tc-99m sulfur colloid kitSolution;Injection, OralPharmalucenceManufacturing Change or Addition
Capexfluocinolone acetonideShampoo;TopicalGalderma Labs LpManufacturing Change or Addition
CialistadalafilTablet;OralLillyLabeling Revision
Cordaroneamiodarone hydrochlorideTablet;OralWyeth Pharms IncLabeling Revision
DalfampridinedalfampridineTablet, Extended Release;OralRoxaneTentative Approval
Dextroamphetamine Saccharate; Amphetamine Aspartate Monohydrate; Dextroamphetamine Sulfate; Amphetamine Sulfatedextroamphetamine saccharate;amphetamine aspartate monohydrate;dextroamphetamine sulfate;amphetamine sulfateCapsule, Extended Release;OralPar Pharm IncTentative Approval
Diclofenac Sodiumdiclofenac sodiumSolution;TopicalLupin LtdTentative Approval
Humulin Ninsulin susp isophane recombinant humanInjectable;InjectionLillyManufacturing Change or Addition
Kenalogtriamcinolone acetonideCream;TopicalDelcor Asset CorpManufacturing Change or Addition
LatanoprostlatanoprostSolution/Drops;OphthalmicFdc LtdApproval
Lenvimalenvatinib mesylateCapsule;OralEisai IncLabeling Revision
Milnacipran Hydrochloridemilnacipran hydrochlorideTablet;OralAmneal PharmApproval
Nithiodotesodium nitrite; sodium thiosulfateSolution, Solution;Intravenous, IntravenousHope PharmsManufacturing Change or Addition
Norethindrone Acetate; Ethinyl Estradiol; Ethinyl Estradiol; Ferrous Fumaratenorethindrone acetate;ethinyl estradiol;ethinyl estradiol;ferrous fumarateTablet;OralGlenmark Pharms LtdTentative Approval
Olmesartan Medoxomil; Hydrochlorothiazideolmesartan medoxomil; hydrochlorothiazideTablet; OralMylan PharmaTentative Approval
OrfadinnitisinoneSuspension;OralSwedish OrphanApproval
PomalystpomalidomideCapsule;OralCelgeneSupplement
RanexaranolazineTablet, Extended Release;OralGileadManufacturing Change or Addition
RevlimidlenalidomideCapsule;OralCelgeneSupplement
RhinocortbudesonideSpray, Metered;NasalAstrazeneca PharmsLabeling Revision
Rhinocort AllergybudesonideSpray, Metered;NasalAstrazeneca PharmsLabeling Revision
SomavertpegvisomantInjectable;SubcutaneousPharmacia and UpjohnManufacturing Change or Addition
TelmisartantelmisartanTablet;OralHetero Labs Ltd VApproval
ThalomidthalidomideCapsule;OralCelgeneSupplement
Tivicaydolutegravir sodiumTablet;OralViiv HlthcareEfficacy Supplement with Clinical Data to Support
Varubirolapitant hydrochlorideTablet;OralTesaro IncManufacturing Change or Addition
Victozaliraglutide recombinantSolution;SubcutaneousNovo Nordisk IncEfficacy Supplement with Clinical Data to Support
Viekira Pak (Copackaged)dasabuvir sodium ; ombitasvir; paritaprevir; ritonavirTablet, Tablet;OralAbbvie IncEfficacy Supplement with Clinical Data to Support
Zometazoledronic acidInjectable;Iv (Infusion)NovartisManufacturing Change or Addition

 

Page Last Updated: 04/29/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.