Drugs

New and Generic Drug Approvals

 

June 28, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Epclusasofosbuvir; velpatasvirTablet;OralGilead Sciences IncApproval
ImbruvicaibrutinibCapsule;OralPharmacyclics IncLabeling Revision

 

June 27, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
ActigallursodiolCapsule;OralAllergan Sales LlcManufacturing Change or Addition
Doxycycline Hyclatedoxycycline hyclateCapsule;OralAmneal PharmsApproval
ImbruvicaibrutinibCapsule;OralPharmacyclics IncManufacturing Change or Addition
ZmaxazithromycinFor Suspension, Extended Release;OralPf Prism CvManufacturing Change or Addition

 

June 24, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
ChlorzoxazonechlorzoxazoneTablet;OralMikart IncApproval
Demerolmeperidine hydrochlorideInjectable;InjectionHospiraManufacturing Change or Addition
DiazepamdiazepamSolution;OralLannett Holdings IncApproval
DocetaxeldocetaxelInjectable;InjectionHospira IncManufacturing Change or Addition
Humulin Rinsulin humanSolution;SubcutaneousLillyManufacturing Change or Addition
Humulin Rinsulin recombinant humanInjectable;InjectionLillyManufacturing Change or Addition
Humulin R Kwikpeninsulin humanSolution;SubcutaneousLillyManufacturing Change or Addition
Humulin R Peninsulin recombinant humanInjectable;InjectionLillyManufacturing Change or Addition
Pramipexole Dihydrochloridepramipexole dihydrochlorideTablet, Extended Release;OralMacleods Pharms LtdApproval
Ryzodeg 70/30insulin aspart; insulin degludecSolution;SubcutaneousNovo Nordisk IncLabeling Revision
Tresibainsulin degludecSolution;SubcutaneousNovo Nordisk IncManufacturing Change or Addition
Zaltrapziv-afliberceptInjectable; InjectionSanofi Aventis UsLabeling Revision

 

June 23, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AdapaleneadapaleneGel;TopicalTaroApproval
Bendekabendamustine hydrochlorideSolution;Iv (Infusion)Eagle PharmsLabeling Revision
Donepezil Hydrochloridedonepezil hydrochlorideTablet;OralUnichem Labs LtdApproval
Evzionaloxone hydrochlorideSolution;Intramuscular, SubcutaneousKaleo IncManufacturing Change or Addition
FenofibratefenofibrateTablet;OralMylanApproval
Methylphenidate Hydrochloridemethylphenidate hydrochlorideCapsule, Extended Release;OralWatson Labs IncChemistry New Strength
Morphine Sulfatemorphine sulfateTablet, Extended Release;OralCorepharmaApproval
Norditropinsomatropin recombinantInjectable;InjectionNovo Nordisk IncManufacturing Change or Addition
Norditropin Flexprosomatropin recombinantInjectable;InjectionNovo Nordisk IncManufacturing Change or Addition
Norditropin Nordiflexsomatropin recombinantInjectable;InjectionNovo Nordisk IncManufacturing Change or Addition
Norethindrone Acetate Ethinyl Estradiol; Ferrous Fumaratenorethindrone acetate ethinyl estradiol;ferrous fumarateTablet;OralAmneal PharmsTentative Approval
Nystatin and Triamcinolone Acetonidenystatin; triamcinolone acetonideOintment;TopicalGlenmark Pharms LtdApproval
Olmesartan Medoxomilolmesartan medoxomilTablet;OralGlenmark Pharms LtdTentative Approval
Primaquine Phosphateprimaquine phosphateTablet;OralIngenus Pharms NjApproval
Spirivatiotropium bromidePowder;InhalationBoehringer IngelheimLabeling Revision
VarithenapolidocanolSolution;IntravenousProvensisLabeling Revision
Xyremsodium oxybateSolution;OralJazz PharmsManufacturing Change or Addition
Xyzallevocetirizine dihydrochlorideTablet;OralUcb IncLabeling Revision
Xyzallevocetirizine dihydrochlorideSolution;OralUcb IncLabeling Revision

 

June 22, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Amyvidflorbetapir f-18Solution;IntravenousAvid Radiopharms IncManufacturing Change or Addition
Avycazavibactam sodium; ceftazidimePowder;Iv (Infusion)Cerexa IncEfficacy Supplement with Clinical Data to Support
Conrayiothalamate meglumineInjectable;InjectionLiebel-FlarsheimManufacturing Change or Addition
Conray 43iothalamate meglumineInjectable;InjectionLiebel-FlarsheimManufacturing Change or Addition
Envarsus XrtacrolimusTablet, Extended Release;OralVeloxis Pharms IncLabeling Revision
Harvoniledipasvir; sofosbuvirTablet;OralGilead Sciences IncManufacturing Change or Addition
IbuprofenibuprofenCapsule;OralPuracap Pharm LlcApproval
Maxipimecefepime hydrochlorideInjectable;InjectionHospira IncManufacturing Change or Addition
Ortho Cyclen-21ethinyl estradiol; norgestimateTablet;Oral-21Janssen PharmsManufacturing Change or Addition
Ortho Cyclen-28ethinyl estradiol; norgestimateTablet;Oral-28Janssen PharmsManufacturing Change or Addition
Phoslocalcium acetateCapsule;OralFresenius MedclManufacturing Change or Addition
Phoslo Gelcapscalcium acetateCapsule;OralFresenius MedclManufacturing Change or Addition

 

Page Last Updated: 06/29/2016
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