Drugs

New and Generic Drug Approvals

September 12, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Advil Liqui-GelsibuprofenCapsule;OralPfizerManufacturing Change or Addition
Advil Migraine Liqui-GelsibuprofenCapsule;OralPfizerManufacturing Change or Addition
AfinitoreverolimusTablet;OralNovartisManufacturing Change or Addition
Allegra Allergyfexofenadine hydrochlorideTablet;OralSanofi Aventis UsLabeling Revision
Allegra Hivesfexofenadine hydrochlorideTablet;OralSanofi Aventis UsLabeling Revision
Amlodipine and Valsartanamlodipine;valsartanTablet;OralTorrent Pharms LtdTentative Approval
An-Sulfur Colloidtechnetium tc-99m sulfur colloid kitSolution;Injection, OralPharmalucenceManufacturing Change or Addition
Children's Allegra Allergyfexofenadine hydrochlorideTablet;OralSanofi Aventis UsLabeling Revision
Children's Allegra Hivesfexofenadine hydrochlorideTablet;OralSanofi Aventis UsLabeling Revision
Clindamycin Phosphate and Benzoyl Peroxidebenzoyl peroxide; clindamycin phosphateGel;TopicalMylan Pharms IncManufacturing Change or Addition
DaptomycindaptomycinInjectable;InjectionHospira IncApproval
Emtricitabine;Tenofovir Disoproxil Fumarate;Nevirapineemtricitabine;tenofovir disoproxil fumarate;nevirapineTablet;OralMylan Labs LtdTentative Approval
Forteoteriparatide recombinant humanInjectable;SubcutaneousLillyManufacturing Change or Addition
Glycine 1.5% In Plastic ContainerglycineSolution;IrrigationB BraunManufacturing Change or Addition
Humaloginsulin lispro recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humalog Kwikpeninsulin lispro recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humalog Mix 50/50insulin lispro protamine recombinant; insulin lispro recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humalog Mix 50/50 Kwikpeninsulin lispro protamine recombinant; insulin lispro recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humalog Mix 50/50 Peninsulin lispro protamine recombinant; insulin lispro recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humalog Mix 75/25insulin lispro protamine recombinant; insulin lispro recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humalog Mix 75/25 Kwikpeninsulin lispro protamine recombinant; insulin lispro recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humalog Mix 75/25 Peninsulin lispro protamine recombinant; insulin lispro recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humalog Peninsulin lispro recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humatropesomatropin recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humulin 70/30insulin recombinant human; insulin susp isophane recombinant humanInjectable;InjectionLillyManufacturing Change or Addition
Humulin 70/30 Peninsulin recombinant human; insulin susp isophane recombinant humanInjectable;InjectionLillyManufacturing Change or Addition
Humulin Ninsulin susp isophane recombinant humanInjectable;InjectionLillyManufacturing Change or Addition
Mycophenolate Mofetilmycophenolate mofetilCapsule;OralRoxaneManufacturing Change or Addition
Mycophenolate Mofetilmycophenolate mofetilTablet;OralRoxaneManufacturing Change or Addition
Naprelannaproxen sodiumTablet, Extended Release;OralAlmatica Pharma IncManufacturing Change or Addition
PomalystpomalidomideCapsule;OralCelgeneLabeling Revision
RevlimidlenalidomideCapsule;OralCelgeneLabeling Revision
ThalomidthalidomideCapsule;OralCelgeneSupplement
Vibra-Tabsdoxycycline hyclateTablet;OralPfizerLabeling Revision
VibramycindoxycyclineFor Suspension;OralPfizerLabeling Revision
Vibramycindoxycycline hyclateCapsule;OralPfizerLabeling Revision
Vibramycindoxycycline calciumSuspension;OralPfizerLabeling Revision
Zoloftsertraline hydrochlorideTablet;OralPfizerLabeling Revision
Zoloftsertraline hydrochlorideConcentrate;OralPfizerLabeling Revision

 

September 11, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Argatroban In Sodium ChlorideargatrobanInjectable;Iv (Infusion)SandozManufacturing Change or Addition
Dorzolamide Hydrochloridedorzolamide hydrochlorideSolution;OphthalmicWatson Labs IncApproval
HectoroldoxercalciferolInjectable;InjectionGenzyme CorpManufacturing Change or Addition
Levalbuterol Hydrochloridelevalbuterol hydrochlorideSolution;InhalationTeva ParenteralApproval
MicronornorethindroneTablet;Oral-28Janssen PharmsManufacturing Change or Addition
Modicon 28ethinyl estradiol; norethindroneTablet;Oral-28Janssen PharmsManufacturing Change or Addition
Montelukast Sodiummontelukast sodiumTablet;OralMacleods Pharms LtdApproval
Opcicon One-SteplevonorgestrelTablet;OralSun Pharm IndsApproval
Ortho-Novum 1/35-28ethinyl estradiol; norethindroneTablet;Oral-28Janssen PharmsManufacturing Change or Addition
Ortho-Novum 7/7/7-21ethinyl estradiol; norethindroneTablet;Oral-21Janssen PharmsManufacturing Change or Addition
Ortho-Novum 7/7/7-28ethinyl estradiol; norethindroneTablet;Oral-28Janssen PharmsManufacturing Change or Addition

 

September 10, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Contravenaltrexone hydrochloride;bupropion hydrochlorideTablet, Extended Release;OralOrexigen Therapeutics IncApproval
EmsamselegilineFilm, Extended Release;TransdermalSomersetEfficacy Supplement with Clinical Data to Support
EmsamselegilineFilm, Extended Release;TransdermalSomersetLabeling Revision
EmsamselegilineSystem; TransdermalSomersetApproval
FamciclovirfamciclovirTablet;OralHetero Labs Ltd VApproval
Montelukast Sodiummontelukast sodiumTablet;OralHetero Drugs LtdApproval
MucinexguaifenesinTablet, Extended Release;OralReckitt BenckiserManufacturing Change or Addition
Oxycodone Hydrochlorideoxycodone hydrochlorideSolution;OralLannett Holdings IncApproval
OxytocinoxytocinInjectable;InjectionFresenius Kabi UsaManufacturing Change or Addition
Pantoprazole Sodiumpantoprazole sodiumTablet, Delayed Release;OralHetero Labs Ltd VApproval
XtandienzalutamideCapsule;OralAstellasEfficacy Supplement with Clinical Data to Support

 

September 9, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Argatroban In Sodium ChlorideargatrobanInjectable;Iv (Infusion)Eagle PharmsLabeling Revision
Iclusigponatinib hydrochlorideTablet;OralAriadManufacturing Change or Addition
Levocetirizine Dihydrochloridelevocetirizine dihydrochlorideTablet;OralSciegen Pharms IncApproval
Namenda Xrmemantine hydrochlorideCapsule, Extended Release;OralForest LabsManufacturing Change or Addition
TacrolimustacrolimusOintment;TopicalFougera Pharms IncApproval
Ultratagtechnetium tc-99m red blood cell kitInjectable;InjectionMallinckrodtManufacturing Change or Addition
Unithroidlevothyroxine sodiumTablet;OralStevens JManufacturing Change or Addition

 

September 8, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Bonivaibandronate sodiumInjectable;IntravenousRocheManufacturing Change or Addition
Brintellixvortioxetine hydrobromideTablet;OralTakeda Pharms UsaManufacturing Change or Addition
Buprenorphine and Naloxonebuprenorphine hydrocloride; naloxone hydrochlorideTablet;SublingualTeva Pharms UsaApproval
Dextrose 10% In Plastic ContainerdextroseInjectable;InjectionHospiraManufacturing Change or Addition
Dextrose 5% and Lactated Ringer's In Plastic Containercalcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactateInjectable;InjectionHospiraManufacturing Change or Addition
Dextrose 5% and Sodium Chloride 0.45% In Plastic Containerdextrose; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Dextrose 5% and Sodium Chloride 0.9% In Plastic Containerdextrose; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
KalbitorecallantideInjectable; InjectionDyax Corp.Labeling Revision
Lactated Ringer's In Plastic Containercalcium chloride; potassium chloride; sodium chloride; sodium lactateInjectable;InjectionHospiraManufacturing Change or Addition
NitrofurantoinnitrofurantoinSuspension;OralNovel Labs IncApproval
Normosol-M and Dextrose 5% In Plastic Containerdextrose; magnesium acetate; potassium acetate; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Ondansetron Hydrochlorideondansetron hydrochlorideInjectable;InjectionQilu Pharma Co LtdApproval
Potassium Chloride 10meq In Dextrose 5% and Lactated Ringer's In Plastic Containercalcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactateInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 10meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 10meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 15meq In Dextrose 5% and Lactated Ringer's In Plastic Containercalcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactateInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 15meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 15meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 20meq In Dextrose 5% and Lactated Ringer's In Plastic Containercalcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactateInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 20meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 20meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 20meq In Dextrose 5% In Plastic Containerdextrose; potassium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 20meq In Sodium Chloride 0.9% In Plastic Containerpotassium chloride; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 30meq In Dextrose 5% and Lactated Ringer's In Plastic Containercalcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactateInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 30meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 30meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 30meq In Dextrose 5% In Plastic Containerdextrose; potassium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 40meq In Dextrose 5% and Lactated Ringer's In Plastic Containercalcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactateInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 40meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 40meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 40meq In Dextrose 5% In Plastic Containerdextrose; potassium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 40meq In Sodium Chloride 0.9% In Plastic Containerpotassium chloride; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 5meq In Dextrose 5% and Lactated Ringer's In Plastic Containercalcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactateInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 5meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 5meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Ringer's In Plastic Containercalcium chloride; potassium chloride; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Sodium Chloride 0.45% In Plastic Containersodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Sodium Chloride 0.45% In Plastic Containersodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Sodium Chloride 0.9% In Plastic Containersodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Sodium Chloride 0.9% In Plastic Containersodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Sodium Chloride 3% In Plastic Containersodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Sodium Chloride 5% In Plastic Containersodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
VelcadebortezomibInjectable;Intravenous, SubcutaneousMillennium PharmsManufacturing Change or Addition

 

September 6, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Solu-Cortefhydrocortisone sodium succinateInjectable;InjectionPharmacia and UpjohnManufacturing Change or Addition

 

September 5, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Besivancebesifloxacin hydrochlorideSuspension/Drops;OphthalmicBausch and LombManufacturing Change or Addition
CampathalemtuzumabVial; IntravenousIlex PharmaceuticalsLabeling Revision
CerezymeimigluceraseInjectable;InjectionGenzymeManufacturing Change or Addition
Ferric Citrateferric citrateTablet;OralKeryx Biopharma IncApproval
Lantusinsulin glargine recombinantInjectable;InjectionSanofi Aventis UsManufacturing Change or Addition
Lantus Solostarinsulin glargine recombinantInjectable;InjectionSanofi Aventis UsManufacturing Change or Addition
Mirvasobrimonidine tartrateGel;TopicalGalderma Labs LpManufacturing Change or Addition
Mucinex Dmdextromethorphan hydrobromide; guaifenesinTablet, Extended Release;OralReckitt BenckiserManufacturing Change or Addition
Olysiosimeprevir sodiumCapsule;OralJanssen ProdsLabeling Revision
Pegasyspeginterferon alfa-2aSyringeHoffman-La RocheLabeling Revision
Pegasyspeginterferon alfa-2aVial; SubcutaneousHoffman-La RocheLabeling Revision

 

 

 

Page Last Updated: 09/15/2014
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