Drugs

New and Generic Drug Approvals

 

July 29, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Abilify Maintena KitaripiprazoleFor Suspension, Extended Release;IntramuscularOtsuka Pharm Co LtdEfficacy Supplement with Clinical Data to Support
Dianeal 137 W/ Dextrose 1.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareManufacturing Change or Addition
Dianeal 137 W/ Dextrose 2.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareManufacturing Change or Addition
Dianeal 137 W/ Dextrose 4.25% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareManufacturing Change or Addition
Dianeal Pd-1 W/ Dextrose 1.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareManufacturing Change or Addition
Dianeal Pd-1 W/ Dextrose 2.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareManufacturing Change or Addition
Dianeal Pd-1 W/ Dextrose 3.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareManufacturing Change or Addition
Dianeal Pd-1 W/ Dextrose 4.25% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareManufacturing Change or Addition
Dianeal Pd-2 W/ Dextrose 1.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareManufacturing Change or Addition
Dianeal Pd-2 W/ Dextrose 2.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareManufacturing Change or Addition
Dianeal Pd-2 W/ Dextrose 3.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareManufacturing Change or Addition
Dianeal Pd-2 W/ Dextrose 4.25% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareManufacturing Change or Addition
PersantinedipyridamoleTablet;OralBoehringer IngelheimManufacturing Change or Addition
TargretinbexaroteneCapsule;OralValeant LuxembourgEfficacy Supplement with Clinical Data to Support
TestosteronetestosteroneSolution;TopicalActavis Labs Ut IncTentative Approval

 

July 28, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
8-MopmethoxsalenCapsule;OralValeant Pharm IntlManufacturing Change or Addition
Azelastine Hydrochlorideazelastine hydrochlorideSpray, Metered;NasalBreckenridge PharmsApproval
Buprenorphine Hydrochloridebuprenorphine hydrochlorideInjectable;InjectionPar Sterile ProductsApproval
Chirhostimsecretin synthetic humanFor Solution;IntravenousChirhoclinManufacturing Change or Addition
DigoxindigoxinElixir;OralRoxaneLabeling Revision
Exforgeamlodipine besylate; valsartanTablet;OralNovartisLabeling Revision
Exforge Hctamlodipine besylate; hydrochlorothiazide; valsartanTablet;OralNovartisLabeling Revision
Fludeoxyglucose F18fludeoxyglucose f-18Injectable;IntravenousUniv MichiganApproval
Folic Acidfolic acidTablet;OralNuvo Pharm IncApproval
Jentaduetolinagliptin; metformin hydrochlorideTablet;OralBoehringer IngelheimLabeling Revision
Kynamromipomersen sodiumSolution;SubcutaneousGenzyme CorpSupplement
LanoxindigoxinInjectable;InjectionCovis InjectablesLabeling Revision
LanoxindigoxinTablet;OralConcordia Pharms IncLabeling Revision
Lanoxin PediatricdigoxinInjectable;InjectionCovis InjectablesLabeling Revision
OxsoralenmethoxsalenLotion;TopicalValeant Pharm IntlManufacturing Change or Addition
Sodium Chloride 0.9% In Plastic Containersodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Stribildcobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarateTablet;OralGilead Sciences IncLabeling Revision
TradjentalinagliptinTablet;OralBoehringer IngelheimLabeling Revision

 

July 27, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
BravelleurofollitropinInjectable;Intramuscular, SubcutaneousFerringManufacturing Change or Addition
DiovanvalsartanCapsule;OralNovartisLabeling Revision
DiovanvalsartanTablet;OralNovartisLabeling Revision
Diovan Hcthydrochlorothiazide; valsartanTablet;OralNovartisLabeling Revision
Duaveebazedoxifene acetate; estrogens, conjugatedTablet;OralWyeth Pharms PfizerLabeling Revision
ExparelbupivacaineInjectable, Liposomal;InjectionPacira Pharms IncManufacturing Change or Addition
FerahemeferumoxytolSolution;IntravenousAmag Pharms IncManufacturing Change or Addition
Hylenex Recombinanthyaluronidase recombinant humanInjectable;InjectionHalozyme TherapManufacturing Change or Addition
Lithium Carbonatelithium carbonateTablet, Extended Release;OralUnique Pharm LabsApproval
Oxybutynin Chlorideoxybutynin chlorideTablet, Extended Release;OralAmneal PharmsTentative Approval
Ravictiglycerol phenylbutyrateLiquid;OralHorizon Theraps IncManufacturing Change or Addition
TanzeumalbiglutideInjectable;InjectionGlaxosmithkline LlcEfficacy Supplement with Clinical Data to Support
TrulicitydulaglutideInjectable;InjectionEli Lilly and CoSupplement
VitektaelvitegravirTablet;OralGilead Sciences IncLabeling Revision
Ziacbisoprolol fumarate; hydrochlorothiazideTablet;OralTeva WomensManufacturing Change or Addition

 

July 24, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Alfentaalfentanil hydrochlorideInjectable;InjectionAkornLabeling Revision
AripiprazolearipiprazoleTablet;OralApotex IncApproval
DaklinzadaclatasivrTablet;OralBristol Myers SquibbApproval
Diflorasone Diacetatediflorasone diacetateOintment;TopicalVersapharm IncApproval
KyproliscarfilzomibPowder;IntravenousOnyx PharmsEfficacy Supplement with Clinical Data to Support
Lotronexalosetron hydrochlorideTablet;OralPrometheus LabsSupplement
NiacinniacinTablet, Extended Release;OralAmneal PharmsApproval
NimodipinenimodipineCapsule;OralSofgen PharmsApproval
OdomzosonidegibCapsule;OralNovartis Pharms CorpApproval
PraluentalirocumabInjectable;InjectionSanofi AventisApproval
Technivieombitasavir; paritaprevir; ritonavirTablet;OralAbbvie IncApproval

 

July 23, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Amlodipine Besylateamlodipine besylateTablet;OralSovereign PharmsApproval
Aranespdarbepoetin alfaVial; IntravenousAmgenEfficacy Supplement with Clinical Data to Support
Aranespdarbepoetin alfaVial; SubcutaneousAmgenEfficacy Supplement with Clinical Data to Support
Esmolol Hydrochlorideesmolol hydrochlorideInjectable;InjectionAurobindo Pharma LtdApproval
Evotazatazanavir sulfate; cobicistatTablet;OralBristol Myers SquibbLabeling Revision
ExjadedeferasiroxTablet, For Suspension;OralNovartisLabeling Revision
ZyprexaolanzapineTablet;OralLillyLabeling Revision
ZyprexaolanzapineInjectable;IntramuscularLillyLabeling Revision
Zyprexa Relprevvolanzapine pamoateSuspension, Extended Release;IntramuscularEli Lilly CoLabeling Revision
Zyprexa ZydisolanzapineTablet, Orally Disintegrating;OralLillyLabeling Revision

 

Page Last Updated: 07/30/2015
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