Drugs

New and Generic Drug Approvals

January 29, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Evotazatazanavir;cobicistatTablet;OralBristol Myers SquibbApproval
ImbruvicaibrutinibCapsule;OralPharmacyclics IncEfficacy Supplement with Clinical Data to Support
Prezcobixdarunavir;cobicistatTablet;OralJanssen ProdsApproval
Savellamilnacipran hydrochlorideTablet;OralCypress BioscienceLabeling Revision
ZorvolexdiclofenacCapsule;OralIroko Pharms LlcManufacturing Change or Addition

 

January 28, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Kaletralopinavir; ritonavirSolution;OralAbbvieEfficacy Supplement with Clinical Data to Support
Kaletralopinavir; ritonavirTablet;OralAbbvieEfficacy Supplement with Clinical Data to Support
Opana Eroxymorphone hydrochlorideTablet, Extended Release;OralEndo PharmsLabeling Revision
Vancomycin Hydrochloridevancomycin hydrochlorideCapsule;OralLupin LtdApproval

 

January 27, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
CaldoloribuprofenSolution;IntravenousCumberland PharmsLabeling Revision
Hydrocodone Bitartrate and Chlorpheniramine Maleatechlorpheniramine maleate; hydrocodone bitartrateSolution;OralTris Pharma IncApproval
Tasignanilotinib hydrochloride monohydrateCapsule;OralNovartisEfficacy Supplement with Clinical Data to Support
ZortresseverolimusTablet;OralNovartisLabeling Revision

 

January 26, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Angeliqdrospirenone; estradiolTablet;OralBayer HlthcareManufacturing Change or Addition
Breviblocesmolol hydrochlorideInjectable; InjectionBaxter HlthcareManufacturing Change or Addition
Breviblocesmolol hydrochlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Brevibloc Double Strength In Plastic Containeresmolol hydrochlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Brevibloc In Plastic Containeresmolol hydrochlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Copaxoneglatiramer acetateFor Solution;SubcutaneousTeva Pharms UsaManufacturing Change or Addition
Copaxoneglatiramer acetateInjectable;SubcutaneousTeva Pharms UsaManufacturing Change or Addition
Desoxynmethamphetamine hydrochlorideTablet, Extended Release;OralRecordati RareManufacturing Change or Addition
Desoxynmethamphetamine hydrochlorideTablet;OralRecordati RareManufacturing Change or Addition
Dilaudidhydromorphone hydrochlorideTablet;OralPurdue Pharm ProdsManufacturing Change or Addition
Esomeprazole Magnesiumesomeprazole magnesiumCapsule, Delayed Rel Pellets;OralIvax Sub Teva PharmsApproval
Fragmindalteparin sodiumInjectable;InjectionEisai IncLabeling Revision
Fragmindalteparin sodiumInjectable;SubcutaneousEisai IncLabeling Revision
Humaloginsulin lispro recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humalog Kwikpeninsulin lispro recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humalog Peninsulin lispro recombinantInjectable;InjectionLillyManufacturing Change or Addition
KinevacsincalideInjectable;InjectionBraccoManufacturing Change or Addition
Lithostatacetohydroxamic acidTablet;OralMission PharmaManufacturing Change or Addition
Lotensinbenazepril hydrochlorideTablet;OralUs Pharms Holdings ILabeling Revision
Nithiodotesodium nitrite; sodium thiosulfateSolution, Solution;Intravenous, IntravenousHope PharmsManufacturing Change or Addition
OrappimozideTablet;OralTevaManufacturing Change or Addition
Oraversephentolamine mesylateInjectable;InjectionSeptodont HoldingManufacturing Change or Addition
Oxectaoxycodone hydrochlorideTablet;OralAcura Pharms IncLabeling Revision
Oxistatoxiconazole nitrateLotion;TopicalFougera PharmsManufacturing Change or Addition
Septocainearticaine hydrochloride; epinephrine bitartrateInjectable;InjectionDeprocoManufacturing Change or Addition
Seroquel Xrquetiapine fumarateTablet, Extended Release;OralAstrazenecaManufacturing Change or Addition
Sodium Chloride 0.9% In Plastic Containersodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
SpryceldasatinibTablet;OralBristol Myers SquibbManufacturing Change or Addition
Trelstartriptorelin pamoateInjectable;IntramuscularWatson LabsManufacturing Change or Addition
Viagrasildenafil citrateTablet;OralPfizer IrelandManufacturing Change or Addition
VivitrolnaltrexoneFor Suspension, Extended Release;IntramuscularAlkermesManufacturing Change or Addition
Xartemis Xracetaminophen; oxycodone hydrochlorideTablet, Extended Release;OralMallinckrodt IncManufacturing Change or Addition

 

January 23, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AfinitoreverolimusTablet;OralNovartisLabeling Revision
Afinitor DisperzeverolimusTablet, For Suspension;OralNovartis PharmLabeling Revision
Atriplaefavirenz; emtricitabine; tenofovir disoproxil fumarateTablet;OralGileadLabeling Revision
Depo-Proveramedroxyprogesterone acetateInjectable;InjectionPharmacia and UpjohnLabeling Revision
Depo-Subq Provera 104medroxyprogesterone acetateInjectable;SubcutaneousPharmacia and UpjohnLabeling Revision
Flonasefluticasone propionateSpray, Metered;NasalGlaxosmithklineLabeling Revision
Levemirinsulin detemir recombinantInjectable;SubcutaneousNovo Nordisk IncLabeling Revision
Levemir Flexpeninsulin detemir recombinantInjectable;SubcutaneousNovo Nordisk IncLabeling Revision
Levemir Flextouchinsulin detemir recombinantInjectable;SubcutaneousNovo Nordisk IncLabeling Revision
Levemir Innoletinsulin detemir recombinantInjectable;SubcutaneousNovo Nordisk IncLabeling Revision
Levemir Penfillinsulin detemir recombinantInjectable;SubcutaneousNovo Nordisk IncLabeling Revision
Natparaparathyroid hormoneInjectable;InjectionNps Pharms IncApproval
NitrolingualnitroglycerinAerosol;SublingualPohl BoskampLabeling Revision
Nitrolingual PumpspraynitroglycerinSpray, Metered;SublingualPohl BoskampLabeling Revision
Norditropinsomatropin recombinantInjectable;InjectionNovo Nordisk IncLabeling Revision
Norditropin Flexprosomatropin recombinantInjectable;InjectionNovo Nordisk IncLabeling Revision
Norditropin Nordiflexsomatropin recombinantInjectable;InjectionNovo Nordisk IncLabeling Revision
Novologinsulin aspart recombinantInjectable;SubcutaneousNovo Nordisk IncLabeling Revision
Novolog Flexpeninsulin aspart recombinantInjectable;SubcutaneousNovo Nordisk IncLabeling Revision
Novolog Flextouchinsulin aspart recombinantInjectable;SubcutaneousNovo Nordisk IncLabeling Revision
Novolog Innoletinsulin aspart recombinantInjectable;SubcutaneousNovo Nordisk IncLabeling Revision
Novolog Penfillinsulin aspart recombinantInjectable;SubcutaneousNovo Nordisk IncLabeling Revision
PletalcilostazolTablet;OralOtsukaLabeling Revision
Trifericferric pyrophosphate citrateSolutionRockwell MedclApproval
Zytigaabiraterone acetateTablet;OralJanssen BiotechLabeling Revision

 

January 22, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Calcium Acetatecalcium acetateTablet;OralZydus Pharms Usa IncApproval
Doxil (Liposomal)doxorubicin hydrochlorideInjectable, Liposomal;InjectionJanssen Res and DevManufacturing Change or Addition
Raloxifene Hydrochlorideraloxifene hydrochlorideTablet;OralWatson Labs IncApproval
Xopenexlevalbuterol hydrochlorideSolution;InhalationOak Pharms IncEfficacy Supplement with Clinical Data to Support

 

January 21, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
CosentyxsecukinumabInjectable;InjectionNovartis Pharms CorpApproval
M.V.I. Adultascorbic acid; biotin; cyanocobalamin; dexpanthenol; ergocalciferol; folic acid; niacinamide; pyridoxine hydrochloride; riboflavin 5'-phosphate sodium; thiamine hydrochloride; vitamin a; vitamin e; vitamin kInjectable;Iv (Infusion)HospiraLabeling Revision
M.V.I. Adult (Pharmacy Bulk Package)ascorbic acid; biotin; cyanocobalamin; dexpanthenol; ergocalciferol; folic acid; niacinamide; pyridoxine hydrochloride; riboflavin 5'-phosphate sodium; thiamine hydrochloride; vitamin a; vitamin e; vitamin kInjectable;Iv (Infusion)HospiraLabeling Revision
Prestaliaperindopril arginine;amlodipine besylateTablet;OralSymplmed Pharms LlcApproval

 

Page Last Updated: 01/30/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.