USFDA: New and Generic Drug Approvals: 04 SEP 2014

New and Generic Drug Approvals

September 4, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Antara (Micronized)fenofibrateCapsule;OralLupin AtlantisManufacturing Change or Addition
Aristocorttriamcinolone diacetateInjectable;InjectionSandozManufacturing Change or Addition
Aristospantriamcinolone hexacetonideInjectable;InjectionSandozManufacturing Change or Addition
Atazanavir Sulfate;Ritonavir;Lamivudine;Zidovudineatazanavir sulfate;ritonavir;lamivudine;zidovudineTablet;OralMylan Labs LtdTentative Approval
Betamethasone Dipropionatebetamethasone dipropionateCream;TopicalFougera PharmsManufacturing Change or Addition
BusulfexbusulfanInjectable;InjectionOtsuka PharmManufacturing Change or Addition
Epaned Kitenalapril maleateFor Solution;OralSilvergate PharmsEfficacy Supplement with Clinical Data to Support
Infuvite Adultalpha-tocopherol acetate; ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine hydrochloride; riboflavin 5'-phosphate sodium; thiamine hydrochloride; vitamin a palmitate; vitamin kInjectable;InjectionSandozManufacturing Change or Addition
Infuvite Adultalpha-tocopherol acetate; ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine hydrochloride; riboflavin 5'-phosphate sodium; thiamine hydrochloride; vitamin a palmitate; vitamin kInjectable;Iv (Infusion)SandozManufacturing Change or Addition
Infuvite Pediatricascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine; riboflavin; thiamine; tocopherol acetate; vitamin a; vitamin kInjectable;Iv (Infusion)SandozManufacturing Change or Addition
Infuvite Pediatric (Pharmacy Bulk Package)ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine; riboflavin; thiamine; tocopherol acetate; vitamin a; vitamin kInjectable;Iv (Infusion)SandozManufacturing Change or Addition
KeytrudapembrolizumabPowder, For Injection Solution, Lyophilized PowderMerck Sharp DohmeApproval
Lamivudine; Zidovudine; Efavirenzlamivudine;zidovudine;efavirenzTablet;OralMylan Labs LtdTentative Approval
LatissebimatoprostSolution/Drops;TopicalAllerganEfficacy Supplement with Clinical Data to Support
LatissebimatoprostSolution/Drops;TopicalAllerganLabeling Revision
MetrogelmetronidazoleGel;TopicalGalderma Labs LpManufacturing Change or Addition
Moxifloxacin Hydrochloridemoxifloxacin hydrochlorideSolution/Drops;OphthalmicLupin LtdApproval
Novologinsulin aspart recombinantInjectable;SubcutaneousNovo Nordisk IncManufacturing Change or Addition
Novolog Flexpeninsulin aspart recombinantInjectable;SubcutaneousNovo Nordisk IncManufacturing Change or Addition
Novolog Flextouchinsulin aspart recombinantInjectable;SubcutaneousNovo Nordisk IncManufacturing Change or Addition
Novolog Innoletinsulin aspart recombinantInjectable;SubcutaneousNovo Nordisk IncManufacturing Change or Addition
Novolog Mix 50/50insulin aspart protamine recombinant; insulin aspart recombinantInjectable;SubcutaneousNovo Nordisk IncManufacturing Change or Addition
Novolog Mix 70/30insulin aspart protamine recombinant; insulin aspart recombinantInjectable;SubcutaneousNovo Nordisk IncManufacturing Change or Addition
Novolog Mix 70/30 Flexpeninsulin aspart protamine recombinant; insulin aspart recombinantInjectable;SubcutaneousNovo Nordisk IncManufacturing Change or Addition
Novolog Mix 70/30 Penfillinsulin aspart protamine recombinant; insulin aspart recombinantInjectable;SubcutaneousNovo Nordisk IncManufacturing Change or Addition
Novolog Penfillinsulin aspart recombinantInjectable;SubcutaneousNovo Nordisk IncManufacturing Change or Addition
Pradaxadabigatran etexilate mesylateCapsule;OralBoehringer IngelheimLabeling Revision
Zoledronic Acidzoledronic acidInjectable;Iv (Infusion)Usv North AmericaApproval
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