Drugs

New and Generic Drug Approvals

 

July 26, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Aveloxmoxifloxacin hydrochlorideTablet;OralBayer HlthcareLabeling Revision
Avelox In Sodium Chloride 0.8% In Plastic Containermoxifloxacin hydrochlorideSolution;Iv (Infusion)Bayer HlthcareLabeling Revision
Ciprociprofloxacin hydrochlorideTablet;OralBayer HlthcareLabeling Revision
CiprociprofloxacinInjectable;InjectionBayer HlthcareLabeling Revision
CiprociprofloxacinFor Suspension;OralBayer HlthcareLabeling Revision
Cipro In Dextrose 5% In Plastic ContainerciprofloxacinInjectable;InjectionBayer HlthcareLabeling Revision
Cipro Xrciprofloxacin; ciprofloxacin hydrochlorideTablet, Extended Release;OralBayer HlthcareLabeling Revision
DocetaxeldocetaxelInjectable;InjectionAccord HlthcareLabeling Revision
Factivegemifloxacin mesylateTablet;OralLg Life SciencesLabeling Revision
Fosamprenavir Calciumfosamprenavir calciumTablet;OralLupin LtdTentative Approval
LansoprazolelansoprazoleCapsule, Delayed Rel Pellets;OralAnchen PharmsApproval
LevaquinlevofloxacinTablet;OralJanssen PharmsLabeling Revision
LevaquinlevofloxacinInjectable;InjectionJanssen PharmsLabeling Revision
LevaquinlevofloxacinSolution;OralJanssen PharmsLabeling Revision
Levaquin In Dextrose 5% In Plastic ContainerlevofloxacinInjectable;InjectionJanssen PharmsLabeling Revision
Moxifloxacin Hydrochloridemoxifloxacin hydrochlorideSolution;Iv (Infusion)Fresenius Kabi UsaLabeling Revision
NoroxinnorfloxacinTablet;OralMerckLabeling Revision
Testosterone Cypionatetestosterone cypionateInjectable;InjectionHikma FarmaceuticaSupplement
Tranexamic Acidtranexamic acidTablet;OralAmerigen Pharms LtdApproval

 

July 25, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AromasinexemestaneTablet;OralPharmacia and UpjohnEfficacy Supplement with Clinical Data to Support
Bupivacaine Hydrochloridebupivacaine hydrochlorideInjectable;SpinalClarisApproval
ChemetsuccimerCapsule;OralRecordati RareManufacturing Change or Addition
DocetaxeldocetaxelInjectable;InjectionSandozManufacturing Change or Addition
FluoroplexfluorouracilCream;TopicalAqua PharmsLabeling Revision
Heparin Sodium 1,000 Units and Sodium Chloride 0.9% In Plastic Containerheparin sodiumInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Heparin Sodium 2,000 Units and Sodium Chloride 0.9% In Plastic Containerheparin sodiumInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Heparin Sodium 5,000 Units and Sodium Chloride 0.9% In Plastic Containerheparin sodiumInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Idkit:hpcitric acid; urea c-13For Solution, Tablet, For Solution;OralExalenz BioscienceManufacturing Change or Addition
Kadcylaado-trastuzumab emtansineVial; Single-UseGenentechLabeling Revision

 

July 22, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
BrilintaticagrelorTablet;OralAstrazeneca LpLabeling Revision
CerezymeimigluceraseInjectable;InjectionGenzymeManufacturing Change or Addition
Movantiknaloxegol oxalateTablet;OralAstrazeneca PharmsLabeling Revision
Omtrygomega-3-acid ethyl esters type aCapsule;OralTryggManufacturing Change or Addition
RayosprednisoneTablet, Delayed Release;OralHorizon PharmaManufacturing Change or Addition
Sandostatin Laroctreotide acetateInjectable;InjectionNovartisManufacturing Change or Addition
Triamcinolone Acetonidetriamcinolone acetonideOintment;TopicalGlenmark Pharms LtdApproval
Viekira Xrdasabuvir;ombitasvir;paritaprevir;ritonavirTablet, Extended Release;OralAbbvieApproval

 

July 21, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Achromycin Vtetracycline hydrochlorideCapsule;OralHeritage Pharms IncManufacturing Change or Addition
Halaveneribulin mesylateSolution;IntravenousEisai IncManufacturing Change or Addition
IlariscanakinumabInjectable; SubcutaneousNovartis PharmsEfficacy Supplement with Clinical Data to Support
Irbesartan and Hydrochlorothiazidehydrochlorothiazide; irbesartanTablet;OralMylan Pharms IncApproval
RelenzazanamivirPowder;InhalationGlaxosmithklineManufacturing Change or Addition

 

July 20, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Clinolipid 20%olive oil; soybean oilInjectable;InjectionBaxter HlthcareLabeling Revision
EliquisapixabanTablet;OralBristol Myers SquibbLabeling Revision
EpivirlamivudineTablet;OralViiv HlthcareEfficacy Supplement with Clinical Data to Support
EpivirlamivudineSolution;OralViiv HlthcareEfficacy Supplement with Clinical Data to Support
FurosemidefurosemideInjectable;InjectionAmneal Pharms CoApproval
Jenlogaclonidine hydrochlorideTablet, Extended Release;OralConcordia Pharms IncManufacturing Change or Addition
Kapvayclonidine hydrochlorideTablet, Extended Release;OralConcordia Pharms IncManufacturing Change or Addition
Phoxillum B22k 4/0 In Plastic Containercalcium chloride; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphateInjectable;InjectionBaxter HlthcareLabeling Revision
Phoxillum Bk 4/2.5 In Plastic Containercalcium chloride; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphateInjectable;InjectionBaxter HlthcareLabeling Revision
Prismasol B22gk 2/0 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
Prismasol B22gk 2/2.5 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
Prismasol B22gk 4/0 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
Prismasol B22gk 4/2.5 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
Prismasol Bgk 0/2.5 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
Prismasol Bgk 2/0 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
Prismasol Bgk 2/3.5 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
Prismasol Bgk 4/0 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
Prismasol Bgk 4/0/1.2 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
Prismasol Bgk 4/2.5 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
Prismasol Bgk 4/3.5 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
Prismasol Bk 0/0 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
Prismasol Bk 0/0/1.2 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
Prismasol Bk 0/3.5 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
Prismasol Bk 4/2.5 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
YondelistrabectedinPowder;Iv (Infusion)Janssen ProdsLabeling Revision

 

Page Last Updated: 07/27/2016
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