Drugs

New and Generic Drug Approvals

 

July 2, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Orkambilumacaftor/ivacaftorTablet; OralVertex Pharms IncApproval

 

July 1, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Afinitor DisperzeverolimusTablet, For Suspension;OralNovartis PharmManufacturing Change or Addition
FurosemidefurosemideInjectable;InjectionFresenius Kabi UsaManufacturing Change or Addition
Kynamromipomersen sodiumSolution;SubcutaneousGenzyme CorpManufacturing Change or Addition
MycobutinrifabutinCapsule;OralPharmacia and UpjohnLabeling Revision
PriftinrifapentineTablet;OralSanofi Aventis UsLabeling Revision
PrograftacrolimusInjectable;InjectionAstellasManufacturing Change or Addition
Prolensabromfenac sodiumSolution/Drops;OphthalmicBausch and LombManufacturing Change or Addition
Victozaliraglutide recombinantSolution;SubcutaneousNovo Nordisk IncSupplement

 

June 30, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Angeliqdrospirenone; estradiolTablet;OralBayer HlthcareLabeling Revision
DesloratadinedesloratadineSolution;OralTaro Pharm IndsApproval
Enjuviaestrogens, conjugated synthetic bTablet;OralTeva WomensLabeling Revision
Patanololopatadine hydrochlorideSolution/Drops;OphthalmicAlconManufacturing Change or Addition
Prevacid 24 HrlansoprazoleCapsule, Delayed Rel Pellets;OralNovartisLabeling Revision
Rocephinceftriaxone sodiumInjectable;InjectionHoffmann La RocheLabeling Revision
Rocephinceftriaxone sodiumInjectable;Intramuscular, IntravenousHoffmann La RocheLabeling Revision
Rocephin Kitceftriaxone sodium; lidocaineInjectable;InjectionHoffmann La RocheLabeling Revision

 

June 29, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Calcium Acetatecalcium acetateCapsule;OralZydus Pharms Usa IncApproval
Desvenlafaxine Succinatedesvenlafaxine succinateTablet, Extended Release;OralAlembic Pharms LtdApproval
Desvenlafaxine Succinatedesvenlafaxine succinateTablet, Extended Release;OralSandoz IncApproval
Desvenlafaxine Succinatedesvenlafaxine succinateTablet, Extended Release;OralMylan Pharms IncApproval
Desvenlafaxine Succinatedesvenlafaxine succinateTablet, Extended Release;OralLupin LtdApproval
Hydralazine Hydrochloridehydralazine hydrochlorideInjectable;InjectionX-Gen Pharms IncApproval
Tri-Lo-Estaryllaethinyl estradiol; norgestimateTablet;Oral-28Sandoz IncApproval

 

June 26, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Avinzamorphine sulfateCapsule, Extended Release;OralKing Pharms LlcSupplement
Bacteriostatic Water For Injection In Plastic Containersterile water for injectionLiquid;N/AHospiraManufacturing Change or Addition
ButransbuprenorphineFilm, Extended Release;TransdermalPurdue Pharma LpSupplement
Ceftincefuroxime axetilTablet;OralGlaxosmithklineLabeling Revision
Ceftincefuroxime axetilFor Suspension;OralGlaxosmithklineLabeling Revision
Dolophine Hydrochloridemethadone hydrochlorideSyrup;OralRoxaneSupplement
Dolophine Hydrochloridemethadone hydrochlorideTablet;OralRoxaneSupplement
Duragesic-100fentanylFilm, Extended Release;TransdermalJanssen PharmsSupplement
Duragesic-12fentanylFilm, Extended Release;TransdermalJanssen PharmsSupplement
Duragesic-25fentanylFilm, Extended Release;TransdermalJanssen PharmsSupplement
Duragesic-50fentanylFilm, Extended Release;TransdermalJanssen PharmsSupplement
Duragesic-75fentanylFilm, Extended Release;TransdermalJanssen PharmsSupplement
Embedamorphine sulfate; naltrexone hydrochlorideCapsule, Extended Release;OralAlpharma PharmsSupplement
Exalgohydromorphone hydrochlorideTablet, Extended Release;OralMallinckrodt IncSupplement
EzetimibeezetimibeTablet;OralGlenmark Pharms LtdApproval
Hysinglahydrocodone bitartrateTablet, Extended Release;OralPurdue Pharma LpSupplement
JardianceempagliflozinTablet;OralBoehringer IngelheimEfficacy Supplement with Clinical Data to Support
Kadianmorphine sulfateCapsule, Extended Release;OralActavis Labs Ut IncSupplement
Kaletralopinavir; ritonavirCapsule;OralAbbvieEfficacy Supplement with Clinical Data to Support
Kaletralopinavir; ritonavirSolution;OralAbbvieEfficacy Supplement with Clinical Data to Support
Kaletralopinavir; ritonavirTablet;OralAbbvieEfficacy Supplement with Clinical Data to Support
KerydintavaboroleSolution;TopicalAnacor Pharms IncManufacturing Change or Addition
Levocetirizine Dihydrochloridelevocetirizine dihydrochlorideTablet;OralSun Pharm Inds LtdApproval
Ms Continmorphine sulfateTablet, Extended Release;OralPurdue Pharma LpSupplement
Nucynta Ertapentadol hydrochlorideTablet, Extended Release;OralDepomed IncSupplement
Opana Eroxymorphone hydrochlorideTablet, Extended Release;OralEndo PharmsSupplement
Opana Eroxymorphone hydrochlorideTablet, Extended Release;OralEndo PharmsSupplement
Oxycontinoxycodone hydrochlorideTablet, Extended Release;OralPurdue Pharma LpSupplement
Pyridostigmine Bromidepyridostigmine bromideTablet, Extended Release;OralAlvogen IncApproval
Targiniqnaloxone hydrochloride; oxycodone hydrochlorideTablet, Extended Release;OralPurdue Pharma LpSupplement
Tis-U-Solmagnesium sulfate; potassium chloride; potassium phosphate, monobasic; sodium chloride; sodium phosphateSolution;IrrigationBaxter HlthcareManufacturing Change or Addition
Zohydro Erhydrocodone bitartrateCapsule, Extended Release;OralFerrimill LtdSupplement

 

Page Last Updated: 07/02/2015
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