Drugs

New and Generic Drug Approvals

 

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
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;OralAppco Pharma LlcApproval
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

 

May 19, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Achromycin Vtetracycline hydrochlorideCapsule;OralHeritage Pharms IncManufacturing Change or Addition
Atorvastatin Calciumatorvastatin calciumTablet;OralSciegen Pharms IncApproval
Bendamustine Hydrochloridebendamustine hydrochloridePowder;Iv (Infusion)Accord HlthcareApproval
BusulfexbusulfanInjectable;InjectionOtsuka PharmLabeling Revision
FaslodexfulvestrantInjectable;IntramuscularAstrazenecaLabeling Revision
Fentorafentanyl citrateTablet;Buccal, SublingualCephalonManufacturing Change or Addition
Fluocinolone Acetonidefluocinolone acetonideOil;TopicalTaroApproval
Fluocinolone Acetonidefluocinolone acetonideOil;TopicalTaro Pharm IndsApproval
KineretanakinraVial; SubcutaneousBiovitrum AbLabeling Revision
Levothroidlevothyroxine sodiumTablet;OralLloydEfficacy Supplement with Clinical Data to Support
Rosuvastatin Calciumrosuvastatin calciumTablet;OralAlkem Labs LtdTentative Approval
Sodium Fluoride F-18sodium fluoride f-18Injectable;IntravenousKreitchman Pet CtrApproval
VivitrolnaltrexoneFor Suspension, Extended Release;IntramuscularAlkermesManufacturing Change or Addition

 

May 18, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AdrenaclickepinephrineInjectable;Intramuscular, SubcutaneousAmedra PharmsLabeling Revision
AdrenalinepinephrineInjectable;Intramuscular, Intraocular, SubcutaneousPar Sterile ProductsLabeling Revision
AdrenalinepinephrineInjectable;Intramuscular, SubcutaneousPar Sterile ProductsLabeling Revision
Auvi-QepinephrineInjectable;Intramuscular, SubcutaneousKaleo IncLabeling Revision
CuvposaglycopyrrolateSolution;OralMerz PharmsLabeling Revision
Doryxdoxycycline hyclateTablet, Delayed Release;OralMayne PharmaLabeling Revision
Doxtericdoxycycline hyclateTablet, Delayed Release;OralMayne PharmaLabeling Revision
EnteregalvimopanCapsule;OralCubist PharmsSupplement
Epi E Z Pen JrepinephrineInjectable;IntramuscularMylan SpecltLabeling Revision
Epinephrineepinephrine hydrochlorideSolution;Iv (Infusion), Intraocular, Intramuscular, SubcutaneousBelcher Pharms LlcLabeling Revision
EpipenepinephrineInjectable;Intramuscular, SubcutaneousMylan SpecltLabeling Revision
Epipen E Z PenepinephrineInjectable;IntramuscularMylan SpecltLabeling Revision
Epipen Jr.epinephrineInjectable;Intramuscular, SubcutaneousMylan SpecltLabeling Revision
Haldolhaloperidol lactateInjectable;InjectionJanssen PharmsLabeling Revision
Haldolhaloperidol decanoateInjectable;InjectionJanssen PharmsLabeling Revision
LinzesslinaclotideCapsule;OralForest Labs LlcManufacturing Change or Addition
Morphine Sulfatemorphine sulfateSolution;OralTris Pharma IncApproval
Namendamemantine hydrochlorideTablet;OralForest Labs LlcManufacturing Change or Addition
Nutropin Aqsomatropin recombinantInjectable;InjectionGenentechManufacturing Change or Addition
Nutropin Aq Nuspinsomatropin recombinantInjectable;InjectionGenentechManufacturing Change or Addition
Nutropin Aq Pensomatropin recombinantInjectable;InjectionGenentechManufacturing Change or Addition
Orkambiivacaftor; lumacaftorTablet;OralVertex Pharms IncLabeling Revision
PregabalinpregabalinCapsule;OralMacleods Pharms LtdTentative Approval
Regonolpyridostigmine bromideInjectable;InjectionSandozManufacturing Change or Addition
Sodium Chloride 0.9% In Plastic Containersodium chlorideInjectable;InjectionJubilant HollistrstrApproval
Sublimaze Preservative Freefentanyl citrateInjectable;InjectionAkornManufacturing Change or Addition
TecentriqatezolizumabInjectable;InjectionGenentech IncApproval
Twinject 0.15epinephrineInjectable;Intramuscular, SubcutaneousAmedra PharmsLabeling Revision
Twinject 0.3epinephrineInjectable;Intramuscular, SubcutaneousAmedra PharmsLabeling Revision
TysabrinatalizumabVial; Single-UseBiogen IdecLabeling Revision

 

May 17, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Adalat CcnifedipineTablet, Extended Release;OralAlvogenManufacturing Change or Addition
Cis-Mdptechnetium tc-99m medronate kitInjectable;InjectionPharmalucenceManufacturing Change or Addition
Fludarabine Phosphatefludarabine phosphateInjectable;InjectionSandozManufacturing Change or Addition
Imodium A-Dloperamide hydrochlorideSolution;OralJ and J Consumer IncManufacturing Change or Addition
Imodium A-Dloperamide hydrochlorideSuspension;OralJ and J Consumer IncManufacturing Change or Addition
Namenda Xrmemantine hydrochlorideCapsule, Extended Release;OralForest Labs LlcManufacturing Change or Addition
OpdivonivolumabInjectable;InjectionBristol Myers SquibbApproval
Quetiapine Fumaratequetiapine fumarateTablet;OralMacleods Pharms LtdApproval
TaxoteredocetaxelInjectable;InjectionSanofi Aventis UsManufacturing Change or Addition
VivitrolnaltrexoneFor Suspension, Extended Release;IntramuscularAlkermesSupplement
VivlodexmeloxicamCapsule;OralIroko Pharms LlcManufacturing Change or Addition
ZarontinethosuximideCapsule;OralParke DavisLabeling Revision
Zytigaabiraterone acetateTablet;OralJanssen BiotechLabeling Revision

 

Page Last Updated: 05/25/2016
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