Drugs

New and Generic Drug Approvals

 

February 11, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Atriplaefavirenz; emtricitabine; tenofovir disoproxil fumarateTablet;OralGileadLabeling Revision
Benicar Hcthydrochlorothiazide; olmesartan medoxomilTablet;OralDaiichi SankyoLabeling Revision
Clindesseclindamycin phosphateCream;VaginalElan Pharma Intl LtdManufacturing Change or Addition
Desogendesogestrel; ethinyl estradiolTablet;Oral-21Organon Usa IncManufacturing Change or Addition
Desogendesogestrel; ethinyl estradiolTablet;Oral-28Organon Usa IncManufacturing Change or Addition
Epinephrineepinephrine hydrochlorideSolution;Iv (Infusion), IntraocularBelcher Pharms LlcEfficacy Supplement with Clinical Data to Support
Glucagenglucagon hydrochloride recombinantInjectable;InjectionNovo NordiskManufacturing Change or Addition
Jentaduetolinagliptin; metformin hydrochlorideTablet;OralBoehringer IngelheimManufacturing Change or Addition
Lupron Depotleuprolide acetateInjectable;InjectionAbbvie Endocrine IncManufacturing Change or Addition
ViberzieluxadolineTablet;OralForest Tosara LtdLabeling Revision

 

February 10, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Gonal-Ffollitropin alfa/betaInjectable;SubcutaneousEmd SeronoManufacturing Change or Addition
Gonal-F Rfffollitropin alfa/betaInjectable;SubcutaneousEmd SeronoManufacturing Change or Addition
Levofloxacin In Dextrose 5% In Plastic ContainerlevofloxacinInjectable;InjectionAurobindo Pharma LtdApproval
OmeprazoleomeprazoleTablet, Delayed Release;OralDexcel PharmaLabeling Revision
Prismasol B22gk 2/0 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Prismasol B22gk 2/2.5 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Prismasol B22gk 4/0 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Prismasol B22gk 4/2.5 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Prismasol Bgk 0/2.5 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Prismasol Bgk 2/0 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Prismasol Bgk 2/3.5 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Prismasol Bgk 4/0 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Prismasol Bgk 4/0/1.2 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Prismasol Bgk 4/2.5 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Prismasol Bgk 4/3.5 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Prismasol Bk 0/0 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Prismasol Bk 0/0/1.2 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Prismasol Bk 0/3.5 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Prismasol Bk 4/2.5 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Sirturobedaquiline fumarateTablet;OralJanssen TherapManufacturing Change or Addition
Tagrissoosimertinib mesylateTablet;OralAstrazeneca PharmsManufacturing Change or Addition

 

February 9, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Atacandcandesartan cilexetilTablet;OralAstrazenecaLabeling Revision
Atacand Hctcandesartan cilexetil; hydrochlorothiazideTablet;OralAstrazenecaLabeling Revision
Bupropion Hydrochloridebupropion hydrochlorideTablet, Extended Release;OralInvagen PharmsApproval
Compleraemtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarateTablet;OralGilead Sciences IncLabeling Revision
Dexmedetomidine Hydrochloridedexmedetomidine hydrochlorideSolution;Iv (Infusion)Hq Spclt PharmaManufacturing Change or Addition
RisperdalrisperidoneTablet;OralJanssen PharmsManufacturing Change or Addition
Ritalin Lamethylphenidate hydrochlorideCapsule, Extended Release;OralNovartisManufacturing Change or Addition
Zoledronic Acidzoledronic acidInjectable;InjectionPfizer IncTentative Approval

 

February 8, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
CaverjectalprostadilInjectable;InjectionPharmacia and UpjohnManufacturing Change or Addition
Clinolipid 20%olive oil; soybean oilInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
CuvposaglycopyrrolateSolution;OralMerz PharmsManufacturing Change or Addition
ImbruvicaibrutinibCapsule;OralPharmacyclics IncManufacturing Change or Addition
Lotrelamlodipine besylate; benazepril hydrochlorideCapsule;OralNovartisManufacturing Change or Addition
OmeprazoleomeprazoleTablet, Delayed Release;OralDexcel PharmaManufacturing Change or Addition
Xeljanztofacitinib citrateTablet;OralPf Prism CvSupplement

 

February 5, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AncobonflucytosineCapsule;OralValeantManufacturing Change or Addition
Avalidehydrochlorothiazide; irbesartanTablet;OralSanofi Aventis UsLabeling Revision
AvaproirbesartanTablet;OralSanofi Aventis UsLabeling Revision
Beprevebepotastine besilateSolution/Drops;OphthalmicBausch and Lomb IncManufacturing Change or Addition
Daklinzadaclatasvir dihydrochlorideTablet;OralBristol-Myers SquibbGeneral Efficacy (MarkIV)
Daklinzadaclatasvir dihydrochlorideTablet;OralBristol-Myers SquibbSupplement
Dilaudidhydromorphone hydrochlorideSolution;OralPurdue Pharm ProdsManufacturing Change or Addition
JardianceempagliflozinTablet;OralBoehringer IngelheimLabeling Revision
LinezolidlinezolidTablet;OralGate PharmsApproval
OzurdexdexamethasoneImplant;IntravitrealAllerganManufacturing Change or Addition
RayosprednisoneTablet, Delayed Release;OralHorizon PharmaManufacturing Change or Addition
Relistormethylnaltrexone bromideSolution;SubcutaneousSalix PharmsManufacturing Change or Addition
Sernivobetamethasone dipropionateSpray;TopicalPromius Pharma LlcApproval
Taclonexbetamethasone dipropionate; calcipotriene hydrateSuspension;TopicalLeo Pharma AsManufacturing Change or Addition

 

Page Last Updated: 02/12/2016
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