Thursday, July 14, 2016

New and Generic Drug Approvals FDA July-13-2016


New and Generic Drug Approvals

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Amlodipine Besylateamlodipine besylateTablet;OralPolygen PharmsApproval
Asmanex Hfamometasone furoateAerosol, Metered;InhalationMerck Sharp DohmeEfficacy Supplement with Clinical Data to Support
CialistadalafilTablet;OralLillyManufacturing Change or Addition
Cymbaltaduloxetine hydrochlorideCapsule, Delayed Rel Pellets;OralLillyManufacturing Change or Addition
Duleraformoterol fumarate; mometasone furoateAerosol, Metered;InhalationMerck Sharp DohmeEfficacy Supplement with Clinical Data to Support
Effientprasugrel hydrochlorideTablet;OralEli Lilly and CoEfficacy Supplement with Clinical Data to Support
FaslodexfulvestrantInjectable;IntramuscularAstrazenecaLabeling Revision
Tarkatrandolapril; verapamil hydrochlorideTablet, Extended Release;OralAbbvieLabeling Revision

July 11, 2016
Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AlinianitazoxanideTablet;OralRomarkLabeling Revision
AlinianitazoxanideFor Suspension;OralRomarkLabeling Revision
Brovanaarformoterol tartrateSolution;InhalationSunovionManufacturing Change or Addition
FuradantinnitrofurantoinSuspension;OralShionogi IncManufacturing Change or Addition
GatifloxacingatifloxacinSolution/Drops;OphthalmicAlcon Res LtdApproval
Juxtapidlomitapide mesylateCapsule;OralAegerionManufacturing Change or Addition
Metformin Hydrochloridemetformin hydrochlorideTablet;OralCspc Ouyi Pharm CoApproval
Vilazodone Hydrochloridevilazodone hydrochlorideTablet;OralTeva Pharms UsaTentative Approval
XiidralifitegrastSolution/Drops; OphthalmicShire Dev LlcApproval

July 8, 2016
Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AbsoricaisotretinoinCapsule;OralRanbaxySupplement
Benicarolmesartan medoxomilTablet;OralDaiichi SankyoManufacturing Change or Addition
DexilantdexlansoprazoleCapsule, Delayed Release;OralTakeda Pharms UsaEfficacy Supplement with Clinical Data to Support
Dexilant SolutabdexlansoprazoleTablet, Orally Disintegrating, Delayed Release;OralTakeda Pharms UsaLabeling Revision
DifferinadapaleneGel;TopicalGalderma Labs LpEfficacy Supplement with Clinical Data to Support
Duexisfamotidine; ibuprofenTablet;OralHorizon PharmaManufacturing Change or Addition
Femcon Feethinyl estradiol; norethindroneTablet, Chewable;OralApilManufacturing Change or Addition
Glyxambiempagliflozin; linagliptinTablet;OralBoehringer IngelheimLabeling Revision
Hiconsodium iodide i-131Solution;OralJubilant DraximageLabeling Revision
Humulin Rinsulin humanSolution;SubcutaneousLillyLabeling Revision
Humulin Rinsulin recombinant humanInjectable;InjectionLillyLabeling Revision
Humulin R Kwikpeninsulin humanSolution;SubcutaneousLillyLabeling Revision
Humulin R Peninsulin recombinant humanInjectable;InjectionLillyLabeling Revision
Idkit:hpcitric acid; urea c-13For Solution, Tablet, For Solution;OralExalenz BioscienceManufacturing Change or Addition
JardianceempagliflozinTablet;OralBoehringer IngelheimLabeling Revision
LampreneclofazimineCapsule;OralNovartisLabeling Revision
Latudalurasidone hydrochlorideTablet;OralSunovion Pharms IncManufacturing Change or Addition
LyricapregabalinCapsule;OralPf Prism CvManufacturing Change or Addition
Menopurmenotropins (fsh;lh)Injectable;SubcutaneousFerringManufacturing Change or Addition
Omidriaketorolac tromethamine; phenylephrine hydrochlorideSolution;IrrigationOmerosManufacturing Change or Addition
Pentetate Calcium Trisodiumpentetate calcium trisodiumSolution;Inhalation, IntravenousHameln Pharma PlusManufacturing Change or Addition
RepathaevolocumabInjectable;InjectionAmgen IncEfficacy Supplement with Clinical Data to Support
RepathaevolocumabInjectable;InjectionAmgen IncLabeling Revision
Sodium Iodide I 131sodium iodide i-131Capsule;OralJubilant DraximageLabeling Revision
Synjardyempagliflozin; metformin hydrochlorideTablet;OralBoehringer IngelheimEfficacy Supplement with Clinical Data to Support
Synjardyempagliflozin; metformin hydrochlorideTablet;OralBoehringer IngelheimLabeling Revision
TegretolcarbamazepineSuspension;OralNovartisManufacturing Change or Addition
Tresibainsulin degludecSolution;SubcutaneousNovo Nordisk IncManufacturing Change or Addition
VeregensinecatechinsOintment;TopicalMedigene AgManufacturing Change or Addition

July 7, 2016
Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Bunavailbuprenorphine hydrochloride; naloxone hydrochlorideFilm;BuccalBiodelivery Sci IntlSupplement
CerezymeimigluceraseInjectable;InjectionGenzymeManufacturing Change or Addition
Hydromorphone Hydrochloridehydromorphone hydrochlorideTablet, Extended Release;OralOsmoticaApproval
Intunivguanfacine hydrochlorideTablet, Extended Release;OralShireLabeling Revision
Miliethinyl estradiol; norgestimateTablet;Oral-28Aurobindo Pharma LtdApproval
Suboxonebuprenorphine hydrochloride; naloxone hydrochlorideTablet;SublingualIndivior IncSupplement
Suboxonebuprenorphine hydrochloride; naloxone hydrochlorideFilm;Buccal, SublingualIndivior IncSupplement
Subutexbuprenorphine hydrochlorideTablet;SublingualIndivior IncSupplement
Triamcinolone Acetonidetriamcinolone acetonideLotion;TopicalTeligent Pharma IncApproval
Triamcinolone Acetonidetriamcinolone acetonideLotion;TopicalTeligent Pharma IncApproval
Zubsolvbuprenorphine hydrochloride; naloxone hydrochlorideTablet;SublingualOrexo AbSupplement

July 6, 2016
Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
CubicindaptomycinPowder;IntravenousCubistLabeling Revision
CubicindaptomycinPowder;Iv (Infusion)CubistLabeling Revision
EltrombopageltrombopagTablet;OralHetero Labs Ltd VTentative Approval
Granisetron Hydrochloridegranisetron hydrochlorideInjectable;InjectionAurobindo Pharma LtdApproval
HabitrolnicotineFilm, Extended Release; TransdermalDr Reddys Labs IncLabeling Revision
HabitrolnicotineFilm, Extended Release;TransdermalDr Reddys Labs IncLabeling Revision
NateglinidenateglinideTablet;OralZydus Pharms Usa IncApproval
Tri-Miliethinyl estradiol; norgestimateTablet;Oral-28Aurobindo Pharma LtdApproval
XolairomalizumabVialGenentechEfficacy Supplement with Clinical Data to Support

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Page Last Updated: 07/13/2016 

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