Drugs

New and Generic Drug Approvals

 

May 27, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Axuminfluciclovine (18f)Injectable;InjectionBlue Earth Diagnostics LtdApproval

 

May 26, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
ArgatrobanargatrobanInjectable;InjectionHikma Pharm Co LtdLabeling Revision
BiaxinclarithromycinTablet;OralAbbvieLabeling Revision
BiaxinclarithromycinFor Suspension;OralAbbvieLabeling Revision
Biaxin XlclarithromycinTablet, Extended Release;OralAbbvieLabeling Revision
Cellceptmycophenolate mofetil hydrochlorideInjectable;InjectionRoche PaloManufacturing Change or Addition
Clindamycin Palmitate Hydrochlorideclindamycin palmitate hydrochlorideFor Solution;OralMylan Pharms IncApproval
FanaptiloperidoneTablet;OralVanda Pharms IncEfficacy Supplement with Clinical Data to Support
Fentanyl Citrate Preservative Freefentanyl citrateInjectable;InjectionEurohlth Intl SarlManufacturing Change or Addition
Heparin Sodium 20,000 Units In Dextrose 5% In Plastic Containerheparin sodiumInjectable;InjectionB BraunLabeling Revision
Heparin Sodium 25,000 Units In Dextrose 5% In Plastic Containerheparin sodiumInjectable;InjectionB BraunLabeling Revision
Probuphinebuprenorphine hydrochlorideImplant;ImplantationTitan PharmsApproval
Sterile Water For Injection In Plastic Containersterile water for injectionLiquid;N/ABaxter HlthcareLabeling Revision

 

May 25, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Acular Lsketorolac tromethamineSolution/Drops;OphthalmicAllerganLabeling Revision
AlliorlistatCapsule;OralGlaxosmithkline ConsLabeling Revision
Amrixcyclobenzaprine hydrochlorideCapsule, Extended Release;OralIvax IntlLabeling Revision
ArgatrobanargatrobanInjectable;InjectionPfizerLabeling Revision
ArgatrobanargatrobanInjectable;InjectionFresenius Kabi UsaLabeling Revision
Argatroban In 0.9% Sodium ChlorideargatrobanInjectable;Iv (Infusion)Teva Pharms UsaLabeling Revision
Argatroban In DextroseargatrobanSolution;Iv (Infusion)SandozLabeling Revision
Argatroban In Sodium ChlorideargatrobanInjectable;Iv (Infusion)Eagle PharmsLabeling Revision
Argatroban In Sodium ChlorideargatrobanInjectable;Iv (Infusion)SandozLabeling Revision
Cefazolin In Plastic Containercefazolin sodiumSolution;IntravenousBaxter HlthcareManufacturing Change or Addition
RenovatretinoinCream;TopicalValeant Pharms NorthManufacturing Change or Addition

 

May 24, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Aminosyn-Pf 7%amino acidsInjectable;InjectionHospiraManufacturing Change or Addition
EfavirenzefavirenzTablet;OralStrides PharmaTentative Approval
EyleaafliberceptInjectable; InjectionRegeneron PharmaceuticalsLabeling Revision
Mibelas 24 Feethinyl estradiol; norethindrone acetateTablet, Chewable;OralLupin AtlantisApproval
Olmesartan Medoxomilolmesartan medoxomilTablet;OralMacleods Pharms LtdTentative Approval
Reclastzoledronic acidInjectable;Iv (Infusion)NovartisManufacturing Change or Addition
Rogaine (For Men)minoxidilSolution;TopicalJohnson and JohnsonManufacturing Change or Addition
Rogaine (For Women)minoxidilSolution;TopicalJohnson and JohnsonManufacturing Change or Addition
VoriconazolevoriconazoleTablet;OralAjanta Pharma LtdApproval
VoriconazolevoriconazoleTablet;OralZydus Pharms Usa IncApproval
VoriconazolevoriconazoleTablet;OralAppco Pharma LlcApproval
VoriconazolevoriconazoleTablet;OralNovel Labs IncApproval
VoriconazolevoriconazoleInjectable;InjectionXellia Pharms ApsTentative Approval
Wellbutrin Xlbupropion hydrochlorideTablet, Extended Release;OralValeant IntlManufacturing Change or Addition
ZithromaxazithromycinInjectable;InjectionPfizerLabeling Revision
ZmaxazithromycinFor Suspension, Extended Release;OralPf Prism CvLabeling Revision

 

May 23, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Doxycycline Hyclatedoxycycline hyclateTablet, Delayed Release;OralMylanChemistry New Strength
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
Juxtapidlomitapide mesylateCapsule;OralAegerionLabeling Revision
KyproliscarfilzomibPowder;IntravenousOnyx TherapLabeling Revision
Lystedatranexamic acidTablet;OralFerring Pharms AsManufacturing Change or Addition
Pentobarbital Sodiumpentobarbital sodiumInjectable;InjectionMylan InstitutionalApproval
SeebriglycopyrrolatePowder;InhalationNovartis Pharms CorpManufacturing Change or Addition
TemazepamtemazepamCapsule;OralAmneal PharmsApproval
ZithromaxazithromycinFor Suspension;OralPfizerLabeling Revision
ZithromaxazithromycinFor Suspension;OralPfizerLabeling Revision
ZithromaxazithromycinTablet;OralPfizerLabeling Revision
ZithromaxazithromycinTablet;OralPfizerLabeling Revision
ZithromaxazithromycinTablet;OralPfizerLabeling Revision

 

May 20, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Bendamustine Hydrochloridebendamustine hydrochloridePowder;Iv (Infusion)Hospira IncApproval
Cleocin Phosphate In Dextrose 5% In Plastic Containerclindamycin phosphateInjectable;InjectionPharmacia and UpjohnManufacturing Change or Addition
Cometriqcabozantinib s-malateCapsule;OralExelixisEfficacy Supplement with Clinical Data to Support
DesvenlafaxinedesvenlafaxineTablet, Extended Release;OralAnchen PharmsTentative Approval
Doryxdoxycycline hyclateTablet, Delayed Release;OralMayne PharmaEfficacy Supplement with Clinical Data to Support
Doxtericdoxycycline hyclateTablet, Delayed Release;OralMayne PharmaEfficacy Supplement with Clinical Data to Support
Flovent Hfafluticasone propionateAerosol, Metered;InhalationGlaxo Grp LtdManufacturing Change or Addition
IntelenceetravirineTablet;OralJanssen R and DManufacturing Change or Addition
Invokametcanagliflozin; metformin hydrochlorideTablet;OralJanssen PharmsEfficacy Supplement with Clinical Data to Support
Invokametcanagliflozin; metformin hydrochlorideTablet;OralJanssen PharmsSupplement
InvokanacanagliflozinTablet;OralJanssen PharmsEfficacy Supplement with Clinical Data to Support
InvokanacanagliflozinTablet;OralJanssen PharmsSupplement
KalydecoivacaftorTablet;OralVertex PharmsManufacturing Change or Addition
Kynamromipomersen sodiumSolution;SubcutaneousGenzyme CorpLabeling Revision
Olysiosimeprevir sodiumCapsule;OralJanssen ProdsEfficacy Supplement with Clinical Data to Support
PotigaezogabineTablet;OralGlaxosmithklineLabeling Revision
Proair Hfaalbuterol sulfateAerosol, Metered;InhalationTeva Branded PharmManufacturing Change or Addition
Sandostatin Laroctreotide acetateInjectable;InjectionNovartisManufacturing Change or Addition
SularnisoldipineTablet, Extended Release;OralShionogi IncManufacturing Change or Addition
Tarcevaerlotinib hydrochlorideTablet;OralOsi PharmsEfficacy Supplement with Clinical Data to Support
Veltassapatiromer sorbitex calciumPowder;OralRelypsa IncLabeling Revision
Votrientpazopanib hydrochlorideTablet;OralNovartis Pharms CorpLabeling Revision
ZolmitriptanzolmitriptanTablet;OralAjanta Pharma LtdApproval

 

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