Drugs

New and Generic Drug Approvals

 

May 3, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
BelsomrasuvorexantTablet;OralMerck Sharp DohmeManufacturing Change or Addition
EliquisapixabanTablet;OralBristol Myers SquibbManufacturing Change or Addition
Ganirelix Acetateganirelix acetateInjectable;InjectionOrganon Usa IncManufacturing Change or Addition
Jenlogaclonidine hydrochlorideTablet, Extended Release;OralConcordia Pharms IncManufacturing Change or Addition
Kapvayclonidine hydrochlorideTablet, Extended Release;OralConcordia Pharms IncManufacturing Change or Addition

 

May 2, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Auryxiaferric citrateTablet;OralKeryx BiopharmsManufacturing Change or Addition
Brintellixvortioxetine hydrobromideTablet;OralTakeda Pharms UsaLabeling Revision
Diclofenac Potassiumdiclofenac potassiumFor Solution;OralPar FormApproval
DiflucanfluconazoleTablet;OralPfizerManufacturing Change or Addition
Megacemegestrol acetateSuspension;OralBristol Myers SquibbManufacturing Change or Addition

 

April 29, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Advair Diskus 100/50fluticasone propionate; salmeterol xinafoatePowder;InhalationGlaxo Grp LtdSupplement
Advair Diskus 250/50fluticasone propionate; salmeterol xinafoatePowder;InhalationGlaxo Grp LtdSupplement
Advair Diskus 500/50fluticasone propionate; salmeterol xinafoatePowder;InhalationGlaxo Grp LtdSupplement
AdvilibuprofenTablet;OralPfizerManufacturing Change or Addition
Akovazephedrine sulfateInjectable;InjectionFlamel Ireland LtdApproval
Atrovent Hfaipratropium bromideAerosol, Metered;InhalationBoehringer IngelheimManufacturing Change or Addition
AzacitidineazacitidineInjectable;Intravenous, SubcutaneousMylan InstitutionalApproval
AzacitidineazacitidineInjectable;InjectionActavis LlcApproval
DalfampridinedalfampridineTablet, Extended Release;OralAccord Hlthcare IncTentative Approval
Doxycycline Hyclatedoxycycline hyclateTablet, Delayed Release;OralMylanChemistry New Strength
Entocort EcbudesonideCapsule;OralElan Pharma Intl LtdEfficacy Supplement with Clinical Data to Support
Excedrin (Migraine)acetaminophen; aspirin; caffeineTablet;OralGlaxosmithkline ConsManufacturing Change or Addition
Fesoterodine Fumaratefesoterodine fumarateTablet, Extended Release;OralAurobindo Pharma LtdTentative Approval
FycompaperampanelSuspension;OralEisai IncApproval
Jentaduetolinagliptin; metformin hydrochlorideTablet;OralBoehringer IngelheimManufacturing Change or Addition
Metformin Hydrochloridemetformin hydrochlorideTablet, Extended Release;OralMarksans PharmaApproval
NuplazidpimavanserinTablet;OralAcadia Pharmaceuticals IncApproval
Otovelciprofloxacin;fluocinolone acetonideSolution/Drops;OticLaboratorios Salvat SaApproval
Oxycodone Hydrochlorideoxycodone hydrochlorideTablet;OralCoastal PharmsApproval
Propafenone Hydrochloridepropafenone hydrochlorideCapsule, Extended Release;OralMylan Pharms IncApproval
Rosiglitazonerosiglitazone maleateTablet; OralDr Reddys Labs IncTentative Approval
Rosuvastatin Calciumrosuvastatin calciumTablet;OralWatson Labs IncApproval
Spirivatiotropium bromidePowder;InhalationBoehringer IngelheimManufacturing Change or Addition
TobitobramycinSolution;InhalationNovartis PharmsManufacturing Change or Addition
XalkoricrizotinibCapsule;OralPf Prism CvLabeling Revision
Xofigoradium ra-223 dichlorideSolution;IntravenousBayer HlthcareManufacturing Change or Addition
Zoledronic Acidzoledronic acidSolution;Iv (Infusion)Hospira IncManufacturing Change or Addition

 

April 28, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Adapalene; Benzoyl Peroxideadapalene;benzoyl peroxideGel;TopicalGlenmark Pharms LtdTentative Approval
BicnucarmustineInjectable;InjectionEmcure Pharms LtdLabeling Revision
BivalirudinbivalirudinInjectable;InjectionAccord Hlthcare IncTentative Approval
Cimziacertolizumab pegolInjectable; InjectionUcb IncLabeling Revision
Diclofenac Sodiumdiclofenac sodiumGel;TopicalTaroApproval
Hydralazine Hydrochloridehydralazine hydrochlorideInjectable;InjectionMylan InstitutionalApproval
Kadcylaado-trastuzumab emtansineVial; Single-UseGenentechLabeling Revision
LacosamidelacosamideSolution;OralAmneal PharmsApproval
LacosamidelacosamideTablet;OralActavis Labs Fl IncApproval
LacosamidelacosamideTablet;OralMsn Labs Pvt LtdApproval
LacosamidelacosamideTablet;OralAlembic Pharms LtdApproval
LacosamidelacosamideTablet;OralAurobindo Pharma LtdApproval
LacosamidelacosamideTablet;OralMylan Pharms IncApproval
LacosamidelacosamideTablet;OralSun Pharma GlobalApproval
Mirceramethoxy polyethylene glycol-epoetin betaSolution; InjectionHoffman-La RocheLabeling Revision
NeulastapegfilgrastimSyringeAmgenLabeling Revision
Olmesartan Medoxomilolmesartan medoxomilTablet;OralAmneal Pharms CoTentative Approval
Plasma-Lyte 148 In Water In Plastic Containermagnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconateInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Plasma-Lyte A In Plastic Containermagnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconateInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Proair Respiclickalbuterol sulfatePowder, Metered;InhalationTeva Branded PharmEfficacy Supplement with Clinical Data to Support
Trandatelabetalol hydrochlorideTablet;OralCnty Line PharmsManufacturing Change or Addition
XalkoricrizotinibCapsule;OralPf Prism CvLabeling Revision

 

April 27, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Aranespdarbepoetin alfaVial; IntravenousAmgenLabeling Revision
Aranespdarbepoetin alfaVial; SubcutaneousAmgenLabeling Revision
Bss Pluscalcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphateSolution;IrrigationAlconLabeling Revision
GadavistgadobutrolSolution;IntravenousBayer HlthcareEfficacy Supplement with Clinical Data to Support
Ringer's In Plastic Containercalcium chloride; potassium chloride; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
Sodium Chloride 0.9% In Plastic Containersodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
TemozolomidetemozolomideCapsule;OralLotus Pharm Co LtdApproval

 

April 26, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Acticlatedoxycycline hyclateTablet;OralAqua Pharms LlcLabeling Revision
Acticlate Capdoxycycline hyclateCapsule;OralAqua PharmsApproval
FamotidinefamotidineTablet;OralAurobindo Pharma LtdApproval
Norgestimate and Ethinyl Estradiolethinyl estradiol; norgestimateTablet;Oral-28Lupin LtdApproval
Oxymorphone Hydrochlorideoxymorphone hydrochlorideTablet;OralAurolife Pharma LlcApproval
Simponi AriagolimumabInjectable; InjectionJanssen BiotechLabeling Revision
Sodium Chloride 0.45% In Plastic Containersodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Sodium Chloride 0.9% In Plastic Containersodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Sodium Chloride 3% In Plastic Containersodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Sodium Chloride 5% In Plastic Containersodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
TadalafiltadalafilTablet;OralAurobindo Pharma LtdTentative Approval
Xtampza EroxycodoneCapsule, Extended Release;OralCollegium Pharms IncApproval

 

Page Last Updated: 05/04/2016
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