Drugs

New and Generic Drug Approvals

 

May 1, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AldactonespironolactoneTablet;OralGd Searle LlcManufacturing Change or Addition
Cefuroxime and Dextrose In Duplex Containercefuroxime sodiumInjectable;InjectionB BraunLabeling Revision
EliquisapixabanTablet;OralBristol Myers SquibbManufacturing Change or Addition
Fesoterodine Fumaratefesoterodine fumarateTablet, Extended Release;OralSandoz IncTentative Approval
GilenyafingolimodCapsule;OralNovartisLabeling Revision
Ortho Cyclen-21ethinyl estradiol; norgestimateTablet;Oral-21Janssen PharmsLabeling Revision
Ortho Cyclen-28ethinyl estradiol; norgestimateTablet;Oral-28Janssen PharmsLabeling Revision
Ortho Tri-Cyclenethinyl estradiol; norgestimateTablet;Oral-21Janssen PharmsLabeling Revision
Ortho Tri-Cyclenethinyl estradiol; norgestimateTablet;Oral-28Janssen PharmsLabeling Revision
Ortho Tri-Cyclen 21ethinyl estradiol; norgestimateTablet; Oral-21Ortho Mcneil PharmLabeling Revision
Ortho Tri-Cyclen 28ethinyl estradiol; norgestimateTablet; Oral-28Ortho Mcneil PharmLabeling Revision
TestosteronetestosteroneGel, Metered;TransdermalPerrigo IsraelManufacturing Change or Addition
TestosteronetestosteroneGel;TransdermalPerrigo IsraelManufacturing Change or Addition

 

April 30, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AndrodermtestosteroneFilm, Extended Release;TransdermalActavis Labs Ut IncManufacturing Change or Addition
BelsomrasuvorexantTablet;OralMerck Sharp DohmeManufacturing Change or Addition
Breo Elliptafluticasone furoate; vilanterol trifenatatePowder;InhalationGlaxo Grp LtdEfficacy Supplement with Clinical Data to Support
CalcipotrienecalcipotrieneCream;TopicalGlenmark GenericsTentative Approval
Dilantin-125phenytoinSuspension;OralParke DavisManufacturing Change or Addition
Dilantin-30phenytoinSuspension;OralParke DavisManufacturing Change or Addition
Ionsysfentanyl hydrochlorideSystem;Iontophoresis, TransdermalIncline TherapEfficacy Supplement with Clinical Data to Support
LacosamidelacosamideTablet;OralAmneal PharmsTentative Approval
LacosamidelacosamideTablet;OralAlembic Pharms LtdTentative Approval
LamotriginelamotrigineTablet, Orally Disintegrating;OralPar Pharm IncTentative Approval
OpsumitmacitentanTablet;OralActelion Pharms LtdLabeling Revision
Phoslyracalcium acetateSolution;OralFresenius MedclLabeling Revision
Relistormethylnaltrexone bromideInjectable;SubcutaneousSalix PharmsManufacturing Change or Addition
Relistormethylnaltrexone bromideSolution;SubcutaneousSalix PharmsManufacturing Change or Addition
Silvadenesilver sulfadiazineCream;TopicalKing PharmsManufacturing Change or Addition

 

April 29, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Akynzeonetupitant; palonosetron hydrochlorideCapsule;OralHelsinn HlthcareLabeling Revision
AravaleflunomideTablet;OralSanofi Aventis UsManufacturing Change or Addition
Atrovent Hfaipratropium bromideAerosol, Metered;InhalationBoehringer IngelheimManufacturing Change or Addition
CaracfluorouracilCream;TopicalValeant Pharms NorthManufacturing Change or Addition
Gonal-Ffollitropin alfa/betaInjectable;SubcutaneousEmd SeronoManufacturing Change or Addition
Gonal-F Rfffollitropin alfa/betaInjectable;SubcutaneousEmd SeronoManufacturing Change or Addition
Kybelladeoxycholic acidInjectable;InjectionKythera Biopharma IncApproval
Namendamemantine hydrochlorideTablet;OralForest Labs LlcManufacturing Change or Addition
Oxycodone Hydrochlorideoxycodone hydrochlorideSolution;OralNovel Labs IncApproval
Phoslocalcium acetateCapsule;OralFresenius MedclManufacturing Change or Addition
Phoslo Gelcapscalcium acetateCapsule;OralFresenius MedclManufacturing Change or Addition
Trospium Chloridetrospium chlorideCapsule, Extended Release;OralSandoz IncApproval
Ultravatehalobetasol propionateCream;TopicalRanbaxyManufacturing Change or Addition

 

April 28, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AripiprazolearipiprazoleTablet;OralTeva Pharms UsaApproval
AripiprazolearipiprazoleTablet;OralTeva Pharms UsaApproval
AripiprazolearipiprazoleTablet;OralTeva Pharms UsaApproval
AripiprazolearipiprazoleTablet;OralTorrent Pharms LtdApproval
AripiprazolearipiprazoleTablet;OralAlembic Pharms LtdApproval
AripiprazolearipiprazoleTablet, Orally Disintegrating;OralAlembic Pharms LtdApproval
AripiprazolearipiprazoleTablet;OralHetero Labs Ltd VApproval

 

April 27, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Achromycin Vtetracycline hydrochlorideCapsule;OralHeritage Pharms IncLabeling Revision
Akynzeonetupitant; palonosetron hydrochlorideCapsule;OralHelsinn HlthcareLabeling Revision
Janumetmetformin hydrochloride; sitagliptin phosphateTablet;OralMerck Sharp DohmeLabeling Revision
Janumet Xrmetformin hydrochloride; sitagliptin phosphateTablet, Extended Release;OralMerck Sharp DohmeLabeling Revision
Januviasitagliptin phosphateTablet;OralMerck Sharp DohmeLabeling Revision
NiaspanniacinTablet, Extended Release;OralAbbvieLabeling Revision
Niaspan Titration Starter PackniacinTablet, Extended Release;OralAbbvieLabeling Revision
OtezlaapremilastTablet;OralCelgene CorpManufacturing Change or Addition
Revatiosildenafil citrateTablet;OralPfizerLabeling Revision
Revatiosildenafil citrateSolution;IntravenousPfizerLabeling Revision
Revatiosildenafil citrateFor Suspension;OralPfizerLabeling Revision
Rogaine (For Men)minoxidilSolution;TopicalJohnson and JohnsonLabeling Revision
Rogaine (For Women)minoxidilSolution;TopicalJohnson and JohnsonLabeling Revision
Rogaine Extra Strength (For Men)minoxidilSolution;TopicalJohnson and JohnsonLabeling Revision
Tarcevaerlotinib hydrochlorideTablet;OralOsi PharmsEfficacy Supplement with Clinical Data to Support
Trilipixcholine fenofibrateCapsule, Delayed Release;OralAbbvieLabeling Revision

Page Last Updated: 05/04/2015
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