Drugs

New and Generic Drug Approvals

 

June 23, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Bendekabendamustine hydrochlorideSolution;Iv (Infusion)Eagle PharmsLabeling Revision
Donepezil Hydrochloridedonepezil hydrochlorideTablet;OralUnichem Labs LtdApproval
Evzionaloxone hydrochlorideSolution;Intramuscular, SubcutaneousKaleo IncManufacturing Change or Addition
FenofibratefenofibrateTablet;OralMylanApproval
Methylphenidate Hydrochloridemethylphenidate hydrochlorideCapsule, Extended Release;OralWatson Labs IncChemistry New Strength
Norditropinsomatropin recombinantInjectable;InjectionNovo Nordisk IncManufacturing Change or Addition
Norditropin Flexprosomatropin recombinantInjectable;InjectionNovo Nordisk IncManufacturing Change or Addition
Norditropin Nordiflexsomatropin recombinantInjectable;InjectionNovo Nordisk IncManufacturing Change or Addition
Norethindrone Acetate Ethinyl Estradiol; Ferrous Fumaratenorethindrone acetate ethinyl estradiol;ferrous fumarateTablet;OralAmneal PharmsTentative Approval
Nystatin and Triamcinolone Acetonidenystatin; triamcinolone acetonideOintment;TopicalGlenmark Pharms LtdApproval
Olmesartan Medoxomilolmesartan medoxomilTablet;OralGlenmark Pharms LtdTentative Approval
Primaquine Phosphateprimaquine phosphateTablet;OralIngenus Pharms NjApproval
Spirivatiotropium bromidePowder;InhalationBoehringer IngelheimLabeling Revision
VarithenapolidocanolSolution;IntravenousProvensisLabeling Revision
Xyremsodium oxybateSolution;OralJazz PharmsManufacturing Change or Addition
Xyzallevocetirizine dihydrochlorideTablet;OralUcb IncLabeling Revision
Xyzallevocetirizine dihydrochlorideSolution;OralUcb IncLabeling Revision

 

June 22, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Amyvidflorbetapir f-18Solution;IntravenousAvid Radiopharms IncManufacturing Change or Addition
Avycazavibactam sodium; ceftazidimePowder;Iv (Infusion)Cerexa IncEfficacy Supplement with Clinical Data to Support
Conrayiothalamate meglumineInjectable;InjectionLiebel-FlarsheimManufacturing Change or Addition
Conray 43iothalamate meglumineInjectable;InjectionLiebel-FlarsheimManufacturing Change or Addition
Envarsus XrtacrolimusTablet, Extended Release;OralVeloxis Pharms IncLabeling Revision
Harvoniledipasvir; sofosbuvirTablet;OralGilead Sciences IncManufacturing Change or Addition
Maxipimecefepime hydrochlorideInjectable;InjectionHospira IncManufacturing Change or Addition
Ortho Cyclen-21ethinyl estradiol; norgestimateTablet;Oral-21Janssen PharmsManufacturing Change or Addition
Ortho Cyclen-28ethinyl estradiol; norgestimateTablet;Oral-28Janssen PharmsManufacturing Change or Addition
Phoslocalcium acetateCapsule;OralFresenius MedclManufacturing Change or Addition
Phoslo Gelcapscalcium acetateCapsule;OralFresenius MedclManufacturing Change or Addition

 

June 21, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
DalfampridinedalfampridineTablet, Extended Release;OralSun Pharm Inds LtdTentative Approval
Firmagondegarelix acetatePowder;SubcutaneousFerringManufacturing Change or Addition
Hylenex Recombinanthyaluronidase recombinant humanInjectable;InjectionHalozyme TherapManufacturing Change or Addition
Norgestrel and Ethinyl Estradiolethinyl estradiol; norgestrelTablet;Oral-28Jai Pharma LtdApproval
Osmoprepsodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrateTablet;OralSalix PharmsManufacturing Change or Addition
SabrilvigabatrinTablet;OralLundbeck LlcSupplement
SabrilvigabatrinFor Solution;OralLundbeck LlcSupplement
Taclonexbetamethasone dipropionate; calcipotriene hydrateSuspension;TopicalLeo Pharma AsManufacturing Change or Addition
Technivieombitasvir; paritaprevir; ritonavirTablet;OralAbbvie IncLabeling Revision
Venlafaxine Hydrochloridevenlafaxine hydrochlorideTablet, Extended Release;OralOsmotica PharmManufacturing Change or Addition
Viekira Pak (Copackaged)dasabuvir sodium ; ombitasvir; paritaprevir; ritonavirTablet, Tablet;OralAbbvie IncLabeling Revision

 

June 20, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Amabelzestradiol; norethindrone acetateTablet;OralLupin LtdApproval
Enstilarbetamethasone dipropionate; calcipotrieneAerosol, Foam;TopicalLeo Pharma AsManufacturing Change or Addition
GlycopyrrolateglycopyrrolateTablet;OralNatco Pharma LtdApproval
Sildenafil Citratesildenafil citrateTablet;OralRubicon Res Pvt LtdApproval
Tamifluoseltamivir phosphateCapsule;OralRocheLabeling Revision
Tamifluoseltamivir phosphateFor Suspension;OralRocheLabeling Revision

 

June 17, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AripiprazolearipiprazoleTablet;OralAmneal PharmsApproval
BanzelrufinamideTablet;OralEisai IncManufacturing Change or Addition
Basaglarinsulin glargineSolution;SubcutaneousEli Lilly and CoLabeling Revision
Basaglarinsulin glargineSolution;SubcutaneousEli Lilly and CoManufacturing Change or Addition
Children's MotrinibuprofenSuspension;OralJ and J Consumer IncManufacturing Change or Addition
Combivent Respimatalbuterol sulfate; ipratropium bromideSpray, Metered;InhalationBoehringer IngelheimManufacturing Change or Addition
EfavirenzefavirenzTablet;OralAurobindo Pharma UsaTentative Approval
GemfibrozilgemfibrozilTablet;OralCadila Pharms LtdApproval
Lactated Ringer's In Plastic Containercalcium chloride; potassium chloride; sodium chloride; sodium lactateInjectable;InjectionB BraunManufacturing Change or Addition
LamotriginelamotrigineTablet, Orally Disintegrating;OralSciegen Pharms IncApproval
Miochol-Eacetylcholine chlorideFor Solution;OphthalmicBausch and LombManufacturing Change or Addition
Nexium 24hresomeprazole magnesiumCapsule, Delayed Release;OralAstrazeneca LpManufacturing Change or Addition
Oxtellar XroxcarbazepineTablet, Extended Release;OralSupernus PharmsManufacturing Change or Addition
Prezistadarunavir ethanolateTablet;OralJanssen ProdsEfficacy Supplement with Clinical Data to Support
Prezistadarunavir ethanolateSuspension;OralJanssen ProdsEfficacy Supplement with Clinical Data to Support
Pulmicort FlexhalerbudesonidePowder, Metered;InhalationAstrazenecaManufacturing Change or Addition
RayaldeecalcifediolCapsule, Extended Release;OralOpko Ireland Global Holdings LtdApproval
Sereventsalmeterol xinafoatePowder;InhalationGlaxosmithklineManufacturing Change or Addition
Seroquelquetiapine fumarateTablet;OralAstrazeneca PharmsLabeling Revision
Seroquel Xrquetiapine fumarateTablet, Extended Release;OralAstrazenecaLabeling Revision
TegretolcarbamazepineSuspension;OralNovartisManufacturing Change or Addition
TrileptaloxcarbazepineTablet;OralNovartisManufacturing Change or Addition
TybostcobicistatTablet;OralGilead Sciences IncLabeling Revision
VarithenapolidocanolSolution;IntravenousProvensisManufacturing Change or Addition

 

Page Last Updated: 06/24/2016
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