Drugs

New and Generic Drug Approvals

 

May 29, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AngiomaxbivalirudinInjectable;IntravenousMedicines CoManufacturing Change or Addition
CarnitorlevocarnitineSolution;OralSigma TauLabeling Revision
CarnitorlevocarnitineTablet;OralSigma TauLabeling Revision
CarnitorlevocarnitineSolution;OralSigma TauLabeling Revision
CarnitorlevocarnitineInjectable;InjectionSigma TauLabeling Revision
Carnitor SflevocarnitineSolution;OralSigma TauLabeling Revision
Clindamycin Phosphateclindamycin phosphateSolution;TopicalVintage PharmsApproval
DiflucanfluconazoleTablet;OralPfizerManufacturing Change or Addition
Foscavirfoscarnet sodiumInjectable;InjectionClinigen HlthcareManufacturing Change or Addition
Kadcylaado-trastuzumab emtansineVial; Single-UseGenentechLabeling Revision
Oxsoralen-UltramethoxsalenCapsule;OralDow PharmManufacturing Change or Addition
PerjetapertuzumabVial; Single-UseGenentechLabeling Revision
Sodium Sulfate;Potassium Sulfate;Magnesium Sulfatesodium sulfate;potassium sulfate;magnesium sulfateSolution;OralNovel Labs IncTentative Approval
Vireadtenofovir disoproxil fumarateTablet;OralGilead Sciences IncEfficacy Supplement with Clinical Data to Support
Vireadtenofovir disoproxil fumaratePowder;OralGilead Sciences IncEfficacy Supplement with Clinical Data to Support

 

May 28, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Desmopressin Acetatedesmopressin acetateTablet;OralGlenmark Pharms LtdApproval
Drospirenone;Ethinyl Estradiol;Levomefolate Calcium;Levomefolate Calciumdrospirenone;ethinyl estradiol;levomefolate calcium;levomefolate calciumTablet;OralWatson LabsTentative Approval
RapamunesirolimusSolution;OralPf Prism CvEfficacy Supplement with Clinical Data to Support
RapamunesirolimusTablet;OralPf Prism CvEfficacy Supplement with Clinical Data to Support
Vazculepphenylephrine hydrochlorideSolution;Iv (Infusion)Eclat Pharms LlcLabeling Revision

 

May 27, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AsacolmesalamineTablet, Delayed Release;OralWarner Chilcott LlcEfficacy Supplement with Clinical Data to Support
Dylojectdiclofenac sodiumSolution;IntravenousJavelin Pharms IncManufacturing Change or Addition
ExparelbupivacaineInjectable, Liposomal;InjectionPacira Pharms IncManufacturing Change or Addition
LinezolidlinezolidTablet;OralAmneal PharmTentative Approval
Maxitroldexamethasone; neomycin sulfate; polymyxin b sulfateSuspension/Drops;OphthalmicAlcon Labs IncManufacturing Change or Addition
NiaspanniacinTablet, Extended Release;OralAbbvieManufacturing Change or Addition
Niaspan Titration Starter PackniacinTablet, Extended Release;OralAbbvieManufacturing Change or Addition
Prezistadarunavir ethanolateTablet;OralJanssen ProdsLabeling Revision
Prezistadarunavir ethanolateSuspension;OralJanssen ProdsLabeling Revision
ViberzieluxadolineTablet;OralFuriex Pharma IncApproval
XifaxanrifaximinTablet;OralSalix PharmsEfficacy Supplement with Clinical Data to Support

 

May 26, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Bupropion Hydrochloridebupropion hydrochlorideTablet, Extended Release;OralPrinston IncApproval
Cis-Mdptechnetium tc-99m medronate kitInjectable;InjectionPharmalucenceManufacturing Change or Addition
Escitalopram Oxalateescitalopram oxalateSolution;OralAntrim Pharms LlcApproval
Haldolhaloperidol lactateInjectable;InjectionJanssen PharmsLabeling Revision
Humaloginsulin lisproInjectable;InjectionEli Lilly and CoApproval
Nutropin Aqsomatropin recombinantInjectable;InjectionGenentechManufacturing Change or Addition
Nutropin Aq Pensomatropin recombinantInjectable;InjectionGenentechManufacturing Change or Addition
PotigaezogabineTablet;OralGlaxosmithklineLabeling Revision
Stratteraatomoxetine hydrochlorideCapsule;OralLillyLabeling Revision

Page Last Updated: 06/01/2015
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