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U.S. Department of Health and Human Services

Drugs

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New and Generic Drug Approvals

 

April 15, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Eligardleuprolide acetateInjectable;SubcutaneousTolmar TherapManufacturing Change or Addition
EszopicloneeszopicloneTablet;OralDr Reddys Labs LtdApproval
EszopicloneeszopicloneTablet;OralRoxaneApproval
EszopicloneeszopicloneTablet;OralGlenmark GenericsApproval
Excedrin (Migraine)acetaminophen; aspirin; caffeineTablet;OralNovartisLabeling Revision
NeurontingabapentinSolution;OralParke DavisManufacturing Change or Addition
RamiprilramiprilCapsule;OralAccord Hlthcare IncApproval
Sitagliptin Phosphatesitagliptin phosphateTablet;OralWatson Labs IncTentative Approval
TanzeumalbiglutideInjectable;InjectionGlaxosmithkline LlcApproval

 

April 14, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Advair Diskus 100/50fluticasone propionate; salmeterol xinafoatePowder;InhalationGlaxo Grp LtdLabeling Revision
Advair Diskus 250/50fluticasone propionate; salmeterol xinafoatePowder;InhalationGlaxo Grp LtdLabeling Revision
Advair Diskus 500/50fluticasone propionate; salmeterol xinafoatePowder;InhalationGlaxo Grp LtdLabeling Revision
DiazepamdiazepamConcentrate;OralLannett Holdings IncApproval
Doxil (Liposomal)doxorubicin hydrochlorideInjectable, Liposomal;InjectionJanssen Res and DevManufacturing Change or Addition
Esmolol Hydrochlorideesmolol hydrochlorideInjectable;InjectionHq Speciality PharmaTentative Approval
Flovent Diskus 100fluticasone propionatePowder;InhalationGlaxo Grp LtdLabeling Revision
Flovent Diskus 250fluticasone propionatePowder;InhalationGlaxo Grp LtdLabeling Revision
Flovent Diskus 50fluticasone propionatePowder;InhalationGlaxo Grp LtdLabeling Revision
Kadianmorphine sulfateCapsule, Extended Release;OralWatson Labs IncManufacturing Change or Addition
Minastrin 24 Feethinyl estradiol; norethindrone acetateTablet, Chewable;OralWarner Chilcott LlcManufacturing Change or Addition
NulojixbelataceptInjectable; InjectionBristol Myers SquibbLabeling Revision
SelzentrymaravirocTablet;OralViiv HlthcareManufacturing Change or Addition
Sereventsalmeterol xinafoatePowder;InhalationGlaxo Grp LtdLabeling Revision
Sumatriptan Succinatesumatriptan succinateInjectable;SubcutaneousAgila SpecltsApproval
Tarcevaerlotinib hydrochlorideTablet;OralOsi PharmsLabeling Revision
ZorvolexdiclofenacCapsule;OralIroko Pharms LlcManufacturing Change or Addition

 

April 11, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
ClopidogrelclopidogrelTablet;OralAmneal PharmsApproval
Fortaz In Plastic Containerceftazidime sodiumInjectable;InjectionCovis PharmaManufacturing Change or Addition
Forteoteriparatide recombinant humanInjectable;SubcutaneousLillyManufacturing Change or Addition
Humaloginsulin lispro recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humalog Kwikpeninsulin lispro recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humalog Mix 50/50insulin lispro protamine recombinant; insulin lispro recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humalog Mix 50/50 Kwikpeninsulin lispro protamine recombinant; insulin lispro recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humalog Mix 50/50 Peninsulin lispro protamine recombinant; insulin lispro recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humalog Mix 75/25insulin lispro protamine recombinant; insulin lispro recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humalog Mix 75/25 Kwikpeninsulin lispro protamine recombinant; insulin lispro recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humalog Mix 75/25 Peninsulin lispro protamine recombinant; insulin lispro recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humalog Peninsulin lispro recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humatropesomatropin recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humulin 70/30insulin recombinant human; insulin susp isophane recombinant humanInjectable;InjectionLillyManufacturing Change or Addition
Humulin 70/30 Peninsulin recombinant human; insulin susp isophane recombinant humanInjectable;InjectionLillyManufacturing Change or Addition
Humulin Ninsulin susp isophane recombinant humanInjectable;InjectionLillyManufacturing Change or Addition
Lidocaine Hydrochloridelidocaine hydrochlorideInjectable; InjectionAgila SpecltsApproval
Ortho Evraethinyl estradiol; norelgestrominFilm, Extended Release;TransdermalJanssen PharmsLabeling Revision
Premarinestrogens, conjugatedTablet;OralWyeth Pharms IncManufacturing Change or Addition
SporanoxitraconazoleCapsule;OralJanssen PharmsManufacturing Change or Addition
VimpatlacosamideSolution;OralUcb IncManufacturing Change or Addition
Xyremsodium oxybateSolution;OralJazz PharmsEfficacy Supplement with Clinical Data to Support

 

April 10, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Promactaeltrombopag olamineTablet;OralGlaxosmithklineLabeling Revision
SpryceldasatinibTablet;OralBristol Myers SquibbLabeling Revision

 

April 9, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Ampicillin Sodiumampicillin sodiumInjectable;InjectionStrides Arcolab LtdApproval
DiamoxacetazolamideCapsule, Extended Release;OralDuramed Pharms BarrManufacturing Change or Addition
Exelonrivastigmine tartrateCapsule;OralNovartisManufacturing Change or Addition
GatifloxacingatifloxacinSolution; OphthalmicHi-Tech PharmacalTentative Approval
Oraversephentolamine mesylateInjectable;InjectionSeptodont HoldingManufacturing Change or Addition
VictrelisboceprevirCapsule;OralMerck Sharp DohmeEfficacy Supplement with Clinical Data to Support
ZolmitriptanzolmitriptanTablet;OralInvagen PharmsApproval

 

April 8, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Augmentin Es-600amoxicillin; clavulanate potassiumFor Suspension;OralDr Reddys Labs IncManufacturing Change or Addition
Isentressraltegravir potassiumTablet;OralMerck Sharp DohmeLabeling Revision
Isentressraltegravir potassiumTablet, Chewable;OralMerck Sharp DohmeLabeling Revision
Isentressraltegravir potassiumPowder;OralMerck Sharp DohmeLabeling Revision
KalydecoivacaftorTablet;OralVertex PharmsLabeling Revision
Ortho-Ceptdesogestrel; ethinyl estradiolTablet;Oral-21Janssen PharmsManufacturing Change or Addition
Ortho-Ceptdesogestrel; ethinyl estradiolTablet;Oral-28Janssen PharmsManufacturing Change or Addition
OxaliplatinoxaliplatinInjectable;Iv (Infusion)Sun Pharma GlobalApproval
OxaliplatinoxaliplatinInjectable;Iv (Infusion)Sun Pharma GlobalTentative Approval
Synthroidlevothyroxine sodiumTablet;OralAbbvieManufacturing Change or Addition