Drugs

New and Generic Drug Approvals

 

April 23, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
BeleodaqbelinostatPowder;Iv (Infusion)Spectrum PharmsManufacturing Change or Addition
Duleraformoterol fumarate; mometasone furoateAerosol, Metered;InhalationMerck Sharp DohmeLabeling Revision
HerceptintrastuzumabVial; IntravenousGenentechLabeling Revision
Iclusigponatinib hydrochlorideTablet;OralAriadManufacturing Change or Addition
Juxtapidlomitapide mesylateCapsule;OralAegerionLabeling Revision
OsphenaospemifeneTablet;OralShionogi IncManufacturing Change or Addition
PomalystpomalidomideCapsule;OralCelgeneEfficacy Supplement with Clinical Data to Support
PomalystpomalidomideCapsule;OralCelgeneLabeling Revision
Spirivatiotropium bromidePowder;InhalationBoehringer IngelheimManufacturing Change or Addition
Valcytevalganciclovir hydrochlorideTablet;OralHoffmann La RocheEfficacy Supplement with Clinical Data to Support
Valcytevalganciclovir hydrochlorideFor Solution;OralHoffmann La RocheEfficacy Supplement with Clinical Data to Support
VarithenapolidocanolSolution;IntravenousProvensisManufacturing Change or Addition
XifaxanrifaximinTablet;OralSalix PharmsManufacturing Change or Addition

 

April 22, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Auvi-QepinephrineInjectable;Intramuscular, SubcutaneousSanofi Aventis UsManufacturing Change or Addition
DaytranamethylphenidateFilm, Extended Release;TransdermalNoven Pharms IncLabeling Revision
Ddavpdesmopressin acetateInjectable;InjectionFerring Pharms IncManufacturing Change or Addition
Erythrocinerythromycin lactobionateInjectable;InjectionHospiraManufacturing Change or Addition
Lotrelamlodipine besylate; benazepril hydrochlorideCapsule;OralNovartisLabeling Revision
Soltamoxtamoxifen citrateSolution;OralDara BiosciencesManufacturing Change or Addition
Spirivatiotropium bromidePowder;InhalationBoehringer IngelheimManufacturing Change or Addition

 

April 21, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Achromycin Vtetracycline hydrochlorideCapsule;OralHeritage Pharms IncManufacturing Change or Addition
Aggrastattirofiban hydrochlorideInjectable;InjectionMedicureLabeling Revision
Aggrastattirofiban hydrochlorideInjectable;InjectionMedicureLabeling Revision
Invirasesaquinavir mesylateCapsule;OralHoffmann La RocheLabeling Revision
Invirasesaquinavir mesylateTablet;OralHoffman La RocheLabeling Revision
KyproliscarfilzomibPowder;IntravenousOnyx PharmsManufacturing Change or Addition
Livalopitavastatin calciumTablet;OralKowa CoManufacturing Change or Addition
Morphine Sulfatemorphine sulfateSolution;OralRoxaneManufacturing Change or Addition
NeurontingabapentinCapsule;OralPfizer PharmsLabeling Revision
NeurontingabapentinTablet;OralPfizer PharmsLabeling Revision
NeurontingabapentinSolution;OralParke DavisLabeling Revision
SelzentrymaravirocTablet;OralViiv HlthcareLabeling Revision
Supprelin Lahistrelin acetateImplant;SubcutaneousEndo PharmManufacturing Change or Addition

 

April 20, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Afrezzainsulin recombinant humanPowder;InhalationSanofi AventisLabeling Revision
Bystolicnebivolol hydrochlorideTablet;OralForest LabsManufacturing Change or Addition
Desmopressin Acetatedesmopressin acetateTablet;OralFerringManufacturing Change or Addition
OsphenaospemifeneTablet;OralShionogi IncManufacturing Change or Addition
Pepcid AcfamotidineTablet;OralMcneil ConsManufacturing Change or Addition

 

April 17, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Adderall 10amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateTablet;OralTeva WomensLabeling Revision
Adderall 12.5amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateTablet;OralTeva WomensLabeling Revision
Adderall 15amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateTablet;OralTeva WomensLabeling Revision
Adderall 20amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateTablet;OralTeva WomensLabeling Revision
Adderall 30amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateTablet;OralTeva WomensLabeling Revision
Adderall 5amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateTablet;OralTeva WomensLabeling Revision
Adderall 7.5amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateTablet;OralTeva WomensLabeling Revision
Adderall Xr 10amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateCapsule, Extended Release;OralShireLabeling Revision
Adderall Xr 15amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateCapsule, Extended Release;OralShireLabeling Revision
Adderall Xr 20amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateCapsule, Extended Release;OralShireLabeling Revision
Adderall Xr 25amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateCapsule, Extended Release;OralShireLabeling Revision
Adderall Xr 30amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateCapsule, Extended Release;OralShireLabeling Revision
Adderall Xr 5amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateCapsule, Extended Release;OralShireLabeling Revision
Afrezzainsulin recombinant humanPowder;InhalationSanofi AventisManufacturing Change or Addition
Augmentin '200'amoxicillin; clavulanate potassiumFor Suspension;OralDr Reddys Labs IncManufacturing Change or Addition
Augmentin '400'amoxicillin; clavulanate potassiumFor Suspension;OralDr Reddys Labs IncManufacturing Change or Addition
BotoxonabotulinumtoxinaVial; Single-UseAllerganEfficacy Supplement with Clinical Data to Support
Botox CosmeticonabotulinumtoxinaVial; Single-UseAllerganEfficacy Supplement with Clinical Data to Support
Concertamethylphenidate hydrochlorideTablet, Extended Release;OralJanssen PharmsLabeling Revision
Cyklokaprontranexamic acidInjectable;InjectionPharmacia and UpjohnManufacturing Change or Addition
Desoxynmethamphetamine hydrochlorideTablet, Extended Release;OralRecordati RareLabeling Revision
Desoxynmethamphetamine hydrochlorideTablet;OralRecordati RareLabeling Revision
Dexedrinedextroamphetamine sulfateCapsule, Extended Release;OralAmedra PharmsLabeling Revision
DiprivanpropofolInjectable;InjectionFresenius Kabi UsaManufacturing Change or Addition
Flolanepoprostenol sodiumInjectable;InjectionGlaxosmithkline LlcManufacturing Change or Addition
Focalindexmethylphenidate hydrochlorideTablet;OralNovartisLabeling Revision
Focalin Xrdexmethylphenidate hydrochlorideCapsule, Extended Release;OralNovartisLabeling Revision
Hylenex Recombinanthyaluronidase recombinant humanInjectable;InjectionHalozyme TherapManufacturing Change or Addition
Iclusigponatinib hydrochlorideTablet;OralAriadManufacturing Change or Addition
Metadate Cdmethylphenidate hydrochlorideCapsule, Extended Release;OralUcb IncLabeling Revision
Methylinmethylphenidate hydrochlorideSolution;OralMallinckrodtLabeling Revision
Methylinmethylphenidate hydrochlorideTablet, Chewable;OralMallinckrodtLabeling Revision
Minocinminocycline hydrochlorideInjectable;InjectionRempex Pharms IncManufacturing Change or Addition
Novologinsulin aspart recombinantInjectable;SubcutaneousNovo Nordisk IncLabeling Revision
Novolog Flexpeninsulin aspart recombinantInjectable;SubcutaneousNovo Nordisk IncLabeling Revision
Novolog Flextouchinsulin aspart recombinantInjectable;SubcutaneousNovo Nordisk IncLabeling Revision
Novolog Innoletinsulin aspart recombinantInjectable;SubcutaneousNovo Nordisk IncLabeling Revision
Novolog Mix 70/30insulin aspart protamine recombinant; insulin aspart recombinantInjectable;SubcutaneousNovo Nordisk IncLabeling Revision
Novolog Mix 70/30 Flexpeninsulin aspart protamine recombinant; insulin aspart recombinantInjectable;SubcutaneousNovo Nordisk IncLabeling Revision
Novolog Mix 70/30 Penfillinsulin aspart protamine recombinant; insulin aspart recombinantInjectable;SubcutaneousNovo Nordisk IncLabeling Revision
Novolog Penfillinsulin aspart recombinantInjectable;SubcutaneousNovo Nordisk IncLabeling Revision
Quillivant Xrmethylphenidate hydrochlorideFor Suspension, Extended Release;OralNextwave PharmsLabeling Revision
Reglanmetoclopramide hydrochlorideTablet;OralAni PharmsManufacturing Change or Addition
Ritalinmethylphenidate hydrochlorideTablet;OralNovartisLabeling Revision
Ritalin Lamethylphenidate hydrochlorideCapsule, Extended Release;OralNovartisLabeling Revision
Ritalin-Srmethylphenidate hydrochlorideTablet, Extended Release;OralNovartisLabeling Revision
Stratteraatomoxetine hydrochlorideCapsule;OralLillyLabeling Revision
Timolol Maleatetimolol maleateSolution/Drops;OphthalmicApotex IncApproval
TricorfenofibrateTablet;OralAbbvieManufacturing Change or Addition
Trilipixcholine fenofibrateCapsule, Delayed Release;OralAbbvieManufacturing Change or Addition
Trokendi XrtopiramateCapsule, Extended Release;OralSupernus PharmsManufacturing Change or Addition
TybostcobicistatTablet;OralGilead Sciences IncManufacturing Change or Addition
Visionbluetrypan blueSolution;OphthalmicDorcManufacturing Change or Addition
Vyvanselisdexamfetamine dimesylateCapsule;OralShire DevelopmentLabeling Revision

 

Page Last Updated: 04/24/2015
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