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U.S. Department of Health and Human Services

Drugs

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New and Generic Drug Approvals

 

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