Drugs

New and Generic Drug Approvals

December 16, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Chg Scrubchlorhexidine gluconateSolution;TopicalEcolabManufacturing Change or Addition
Cida-Statchlorhexidine gluconateSolution;TopicalEcolabManufacturing Change or Addition
DiastatdiazepamGel;RectalValeant Pharms NorthLabeling Revision
Diastat AcudialdiazepamGel;RectalValeant Pharms NorthLabeling Revision
Diclegisdoxylamine succinate; pyridoxine hydrochlorideTablet, Delayed Release;OralDuchesnayLabeling Revision
Primaxincilastatin sodium; imipenemPowder;IntravenousMerckLabeling Revision
Somatuline Depotlanreotide acetateInjectable;SubcutaneousIpsen PharmaSupplement
Wellbutrinbupropion hydrochlorideTablet;OralGlaxosmithklineLabeling Revision
Wellbutrin Srbupropion hydrochlorideTablet, Extended Release;OralGlaxosmithklineLabeling Revision

 

December 15, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AbilifyaripiprazoleTablet;OralOtsukaManufacturing Change or Addition
ArgatrobanargatrobanInjectable;InjectionTeva Pharms Usa IncApproval
Brevital Sodiummethohexital sodiumInjectable;InjectionPar Sterile ProductsManufacturing Change or Addition
Cyklokaprontranexamic acidInjectable;InjectionPharmacia and UpjohnManufacturing Change or Addition
Egriftatesamorelin acetatePowder;SubcutaneousTheratechnologiesManufacturing Change or Addition
Ellenceepirubicin hydrochlorideInjectable;InjectionPfizer IncLabeling Revision
ExparelbupivacaineInjectable, Liposomal;InjectionPacira Pharms IncManufacturing Change or Addition
Firmagondegarelix acetatePowder;SubcutaneousFerringManufacturing Change or Addition
Intralipid 10%soybean oilInjectable;InjectionFreseniusManufacturing Change or Addition
Jakafiruxolitinib phosphateTablet;OralIncyte CorpLabeling Revision
KerydintavaboroleSolution;TopicalAnacor Pharms IncManufacturing Change or Addition
Marcaine Hydrochloridebupivacaine hydrochlorideInjectable;InjectionHospiraManufacturing Change or Addition
Marcaine Hydrochloride Preservative Freebupivacaine hydrochlorideInjectable;InjectionHospiraManufacturing Change or Addition
Marcaine Hydrochloride W/ Epinephrinebupivacaine hydrochloride; epinephrine bitartrateInjectable;InjectionHospiraManufacturing Change or Addition
Marcaine Hydrochloride W/ Epinephrine Preservative Freebupivacaine hydrochloride; epinephrine bitartrateInjectable;InjectionHospiraManufacturing Change or Addition
Signifor LarpasireotideSuspension; Injectable, IntramuscularNovartis Pharms CorpApproval
Tamifluoseltamivir phosphateCapsule;OralRocheManufacturing Change or Addition
Todaynonoxynol-9Sponge;VaginalMayer Labs IncManufacturing Change or Addition
Xopenexlevalbuterol hydrochlorideSolution;InhalationOak Pharms IncManufacturing Change or Addition

 

December 12, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AbilifyaripiprazoleTablet;OralOtsukaEfficacy Supplement with Clinical Data to Support
AbilifyaripiprazoleSolution;OralOtsukaEfficacy Supplement with Clinical Data to Support
AbilifyaripiprazoleTablet, Orally Disintegrating;OralOtsukaEfficacy Supplement with Clinical Data to Support
AbilifyaripiprazoleInjectable;IntramuscularOtsukaEfficacy Supplement with Clinical Data to Support
CyramzaramucirumabInjectable;InjectionEli Lilly and CoLabeling Revision
Ellenceepirubicin hydrochlorideInjectable;InjectionPfizer IncLabeling Revision
HetlioztasimelteonCapsule;OralVanda Pharms IncLabeling Revision
Lotensinbenazepril hydrochlorideTablet;OralUs Pharms Holdings ILabeling Revision
Lotensin Hctbenazepril hydrochloride; hydrochlorothiazideTablet;OralUs Pharms Holdings ILabeling Revision
MicardistelmisartanTablet;OralBoehringer IngelheimLabeling Revision
Micardis Hcthydrochlorothiazide; telmisartanTablet;OralBoehringer IngelheimLabeling Revision
Pulmozymedornase alfaVialGenentechEfficacy Supplement with Clinical Data to Support
Twynstaamlodipine besylate; telmisartanTablet;OralBoehringer IngelheimLabeling Revision
TylenolacetaminophenTablet, Extended Release;OralMcneil ConsLabeling Revision

 

December 11, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AbraxanepaclitaxelFor Suspension;Iv (Infusion)Abraxis BioscienceLabeling Revision
Bloxiverzneostigmine methylsulfateSolution;IntravenousEclat Pharms LlcLabeling Revision
Bromdaybromfenac sodiumSolution/Drops;OphthalmicBausch and Lomb IncManufacturing Change or Addition
Children's MotrinibuprofenSuspension;OralMcneilLabeling Revision
KalydecoivacaftorTablet;OralVertex PharmsManufacturing Change or Addition
LinzesslinaclotideCapsule;OralForest Labs IncManufacturing Change or Addition
Ovidrelchoriogonadotropin alfaInjectable;InjectionEmd SeronoManufacturing Change or Addition
Ovidrelchoriogonadotropin alfaInjectable;SubcutaneousEmd SeronoManufacturing Change or Addition
Suboxonebuprenorphine hydrochloride; naloxone hydrochlorideTablet;SublingualReckitt BenckiserLabeling Revision
Subutexbuprenorphine hydrochlorideTablet;SublingualReckitt BenckiserLabeling Revision
Twynstaamlodipine besylate; telmisartanTablet;OralBoehringer IngelheimManufacturing Change or Addition
VarithenapolidocanolSolution;IntravenousProvensisManufacturing Change or Addition
Xibrombromfenac sodiumSolution/Drops;OphthalmicBausch and Lomb IncManufacturing Change or Addition
Zubsolvbuprenorphine hydrochloride; naloxone hydrochlorideTablet;SublingualOrexo AbManufacturing Change or Addition

 

December 10, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Advair Hfafluticasone propionate; salmeterol xinafoateAerosol, Metered;InhalationGlaxo Grp LtdLabeling Revision
Flovent Hfafluticasone propionateAerosol, Metered;InhalationGlaxo Grp LtdLabeling Revision
Geodonziprasidone hydrochlorideCapsule;OralPfizerLabeling Revision
Geodonziprasidone mesylateInjectable;IntramuscularPfizerLabeling Revision
Geodonziprasidone hydrochlorideSuspension;OralPfizer IncLabeling Revision
Zoledronic Acidzoledronic acidInjectable;Iv (Infusion)Acs Dobfar Info SaLabeling Revision

 

December 9, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Belviqlorcaserin hydrochlorideTablet;OralEisai IncLabeling Revision
ExtranealicodextrinSolution;IntraperitonealBaxter HlthcareLabeling Revision
OnficlobazamTablet;OralLundbeck LlcLabeling Revision
OnficlobazamSuspension;OralLundbeck LlcLabeling Revision

 

December 8, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Delflex W/ Dextrose 1.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealFresenius MedclManufacturing Change or Addition
Delflex W/ Dextrose 1.5% Low Magnesium In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealFresenius MedclManufacturing Change or Addition
Delflex W/ Dextrose 2.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealFresenius MedclManufacturing Change or Addition
Delflex W/ Dextrose 2.5% Low Magnesium In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealFresenius MedclManufacturing Change or Addition
Delflex W/ Dextrose 4.25% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealFresenius MedclManufacturing Change or Addition
Delflex W/ Dextrose 4.25% Low Magnesium In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealFresenius MedclManufacturing Change or Addition
MirenalevonorgestrelIntrauterine Device;IntrauterineBayer HlthcareManufacturing Change or Addition

 

December 5, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Abilify Maintena KitaripiprazoleFor Suspension, Extended Release;IntramuscularOtsuka Pharm Co LtdEfficacy Supplement with Clinical Data to Support
Adriamycin Pfsdoxorubicin hydrochlorideInjectable;InjectionPharmacia and UpjohnManufacturing Change or Addition
Benzaclinbenzoyl peroxide; clindamycin phosphateGel;TopicalValeant BermudaManufacturing Change or Addition
Benzamycinbenzoyl peroxide; erythromycinGel;TopicalValeant IntlManufacturing Change or Addition
Cardiogen-82rubidium chloride rb-82Injectable;InjectionBraccoManufacturing Change or Addition
ExparelbupivacaineInjectable, Liposomal;InjectionPacira Pharms IncLabeling Revision
Heparin Sodiumheparin sodiumInjectable;InjectionPfizerManufacturing Change or Addition
Heparin Sodium Preservative Freeheparin sodiumInjectable;InjectionPfizerManufacturing Change or Addition
Klaronsulfacetamide sodiumLotion;TopicalValeant BermudaManufacturing Change or Addition
Minastrin 24 Feethinyl estradiol; norethindrone acetateTablet, Chewable;OralWarner Chilcott LlcLabeling Revision
NoritatemetronidazoleCream;TopicalValeant BermudaManufacturing Change or Addition
ProliadenosumabInjectable; SubcutaneousAmgenEfficacy Supplement with Clinical Data to Support
TricorfenofibrateTablet;OralAbbottLabeling Revision
XgevadenosumabInjectable; SubcutaneousAmgenEfficacy Supplement with Clinical Data to Support

 

December 4, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Acuvailketorolac tromethamineSolution/Drops;OphthalmicAllerganLabeling Revision
Idamycinidarubicin hydrochlorideInjectable;InjectionPharmacia and UpjohnLabeling Revision
Idamycin Pfsidarubicin hydrochlorideInjectable;InjectionPharmacia and UpjohnLabeling Revision
Jakafiruxolitinib phosphateTablet;OralIncyte CorpEfficacy Supplement with Clinical Data to Support
LastacaftalcaftadineSolution/Drops;OphthalmicAllerganLabeling Revision
MozobilplerixaforSolution;SubcutaneousGenzymeLabeling Revision
Pamidronate Disodiumpamidronate disodiumInjectable;InjectionEurohlth IntlLabeling Revision
Vizamylflutemetamol f-18Injectable;IntravenousGe HealthcareLabeling Revision

 

December 3, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
BlincytoblinatumomabInjectable;InjectionAmgenApproval
IquixlevofloxacinSolution/Drops;OphthalmicSantenLabeling Revision
Premarinestrogens, conjugatedTablet;OralWyeth Pharms IncLabeling Revision
QuixinlevofloxacinSolution/Drops;OphthalmicSantenLabeling Revision
SurvantaberactantSuspension;IntratrachealAbbvieManufacturing Change or Addition
Tecfideradimethyl fumarateCapsule, Delayed Release;OralBiogen Idec IncEfficacy Supplement with Clinical Data to Support
Tecfideradimethyl fumarateCapsule, Delayed Release;OralBiogen Idec IncLabeling Revision
Vibativtelavancin hydrochloridePowder;Iv (Infusion)Theravance BiopharmaLabeling Revision

 

December 2, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AcephenacetaminophenSuppository;RectalG and W LabsManufacturing Change or Addition
Actonelrisedronate sodiumTablet;OralWarner Chilcott LlcManufacturing Change or Addition
Allegra Allergyfexofenadine hydrochlorideTablet;OralSanofi Aventis UsManufacturing Change or Addition
Allegra Hivesfexofenadine hydrochlorideTablet;OralSanofi Aventis UsManufacturing Change or Addition
Bloxiverzneostigmine methylsulfateSolution;IntravenousEclat Pharms LlcManufacturing Change or Addition
Cardenenicardipine hydrochlorideInjectable;InjectionChiesi Usa IncManufacturing Change or Addition
Cardene In 0.83% Sodium Chloride In Plastic Containernicardipine hydrochlorideInjectable;IntravenousChiesi Usa IncManufacturing Change or Addition
Cardene In 0.86% Sodium Chloride In Plastic Containernicardipine hydrochlorideInjectable;IntravenousChiesi Usa IncManufacturing Change or Addition
Cardene In 4.8% Dextrose In Plastic Containernicardipine hydrochlorideInjectable;IntravenousChiesi Usa IncManufacturing Change or Addition
Cardene In 5.0% Dextrose In Plastic Containernicardipine hydrochlorideInjectable;IntravenousChiesi Usa IncManufacturing Change or Addition
Children's Allegra Allergyfexofenadine hydrochlorideTablet;OralSanofi Aventis UsManufacturing Change or Addition
Children's Allegra Hivesfexofenadine hydrochlorideTablet;OralSanofi Aventis UsManufacturing Change or Addition
Coumadinwarfarin sodiumInjectable;InjectionBristol Myers SquibbManufacturing Change or Addition
Coumadinwarfarin sodiumTablet;OralBristol Myers SquibbManufacturing Change or Addition
DelzicolmesalamineCapsule, Delayed Release;OralWarner Chilcott LlcManufacturing Change or Addition
DocetaxeldocetaxelInjectable;InjectionPfizer LabsManufacturing Change or Addition
Dutoprolhydrochlorothiazide; metoprolol succinateTablet, Extended Release;OralCovis Pharma SarlManufacturing Change or Addition
Nexavarsorafenib tosylateTablet;OralBayer HlthcareManufacturing Change or Addition
Procysbicysteamine bitartrateCapsule, Delayed Release;OralRaptor IncManufacturing Change or Addition
SucraidsacrosidaseSolution;OralQol MedclManufacturing Change or Addition
Symbicortbudesonide; formoterol fumarate dihydrateAerosol, Metered;InhalationAstrazenecaManufacturing Change or Addition
TargretinbexaroteneCapsule;OralValeant LuxembourgManufacturing Change or Addition
TobramycintobramycinSolution;Inhalation, NebulizerPulmoflow IncApproval
Vprivvelaglucerase alfaInjectable;Iv (Infusion)Shire Human GeneticManufacturing Change or Addition
Vprivvelaglucerase alfaPowder;Iv (Infusion)Shire Human GeneticManufacturing Change or Addition

 

December 1, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
BimatoprostbimatoprostSolution;OphthalmicApotex IncApproval
Brisdelleparoxetine mesylateCapsule;OralNoven TherapLabeling Revision
Sarafemfluoxetine hydrochlorideTablet;OralWarner Chilcott LlcLabeling Revision

 

November 26, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
CubicindaptomycinInjectable;Iv (Infusion)CubistLabeling Revision
Mytelaseambenonium chlorideTablet;OralSanofi Aventis UsLabeling Revision
Renagelsevelamer hydrochlorideTablet;OralGenzymeLabeling Revision
Renvelasevelamer carbonateTablet;OralGenzymeLabeling Revision
Renvelasevelamer carbonateFor Suspension;OralGenzymeLabeling Revision
Singulairmontelukast sodiumTablet;OralMerckLabeling Revision
Singulairmontelukast sodiumTablet, Chewable;OralMerckLabeling Revision
Singulairmontelukast sodiumGranule;OralMerckLabeling Revision
Tamifluoseltamivir phosphateCapsule;OralRocheLabeling Revision
Tamifluoseltamivir phosphateFor Suspension;OralRocheLabeling Revision

 

November 25, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AmoxilamoxicillinFor Suspension;OralDr Reddys Labs IncLabeling Revision
Bosulifbosutinib monohydrateTablet;OralWyeth Pharms IncLabeling Revision
Bupropion Hydrochloridebupropion hydrochlorideTablet, Extended Release;OralSandozLabeling Revision
Bupropion Hydrochloridebupropion hydrochlorideTablet;OralApotex IncLabeling Revision
Bupropion Hydrochloridebupropion hydrochlorideTablet, Extended Release;OralSun Pharma GlobalLabeling Revision
Bupropion Hydrochloridebupropion hydrochlorideTablet, Extended Release;OralActavis Labs Fl IncLabeling Revision
Bupropion Hydrochloridebupropion hydrochlorideTablet, Extended Release;OralMylanLabeling Revision
Bupropion Hydrochloridebupropion hydrochlorideTablet, Extended Release;OralAnchen PharmsLabeling Revision
Bupropion Hydrochloridebupropion hydrochlorideTablet, Extended Release;OralZydus Pharms Usa IncLabeling Revision
Bupropion Hydrochloridebupropion hydrochlorideTablet, Extended Release;OralJubilant GenericsLabeling Revision
Cymbaltaduloxetine hydrochlorideCapsule, Delayed Rel Pellets;OralLillyLabeling Revision
Divalproex Sodiumdivalproex sodiumTablet, Extended Release;OralReddysLabeling Revision
Divalproex Sodiumdivalproex sodiumTablet, Delayed Release;OralAurobindo Pharma LtdLabeling Revision
Divalproex Sodiumdivalproex sodiumTablet, Extended Release;OralAurobindo Pharma LtdLabeling Revision
LarotidamoxicillinFor Suspension;OralDr Reddys Labs IncLabeling Revision
LucentisranibizumabInjectable; InjectionGenentechEfficacy Supplement with Clinical Data to Support
Norcoacetaminophen; hydrocodone bitartrateTablet;OralWatson LabsLabeling Revision
PriftinrifapentineTablet;OralSanofi Aventis UsEfficacy Supplement with Clinical Data to Support
TopiramatetopiramateCapsule;OralZydus Pharms Usa IncLabeling Revision
Tussicapschlorpheniramine polistirex; hydrocodone polistirexCapsule, Extended Release;OralEcr PharmaLabeling Revision
Voltarendiclofenac sodiumGel;TopicalNovartisLabeling Revision
XalatanlatanoprostSolution/Drops;OphthalmicPharmacia and UpjohnLabeling Revision
ZelborafvemurafenibTablet;OralHoffmann La RocheLabeling Revision

 

 

 

Page Last Updated: 12/17/2014
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