Drugs

New and Generic Drug Approvals

 

September 2, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Avycazavibactam sodium; ceftazidimePowder;Iv (Infusion)Cerexa IncLabeling Revision
Coartemartemether; lumefantrineTablet;OralNovartisManufacturing Change or Addition
Doryxdoxycycline hyclateCapsule, Delayed Release;OralMayne Pharma IntlLabeling Revision
Omtrygomega-3-acid ethyl estersCapsule;OralTryggManufacturing Change or Addition
Treandabendamustine hydrochloridePowder;Iv (Infusion)CephalonLabeling Revision
Treandabendamustine hydrochlorideSolution;Iv (Infusion)CephalonLabeling Revision

 

September 1, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Acthrelcorticorelin ovine triflutateInjectable;InjectionFerringLabeling Revision
CialistadalafilTablet;OralLillyManufacturing Change or Addition
Clinimix E 2.75/10 Sulfite-Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 2.75/25 Sulfite-Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 2.75/5 Sulfite-Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 4.25/10 Sulfite-Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 4.25/20 Sulfite-Free W/ Elect In Dextrose 20% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 4.25/25 Sulfite-Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 4.25/5 Sulfite-Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 5/10 Sulfite-Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 5/15 Sulfite-Free W/ Elect In Dextrose 15% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 5/20 Sulfite-Free W/ Elect In 20% Dextrose W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 5/25 Sulfite-Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 5/35 Sulfite-Free W/ Elect In Dextrose 35% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Dianeal 137 W/ Dextrose 1.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareLabeling Revision
Dianeal 137 W/ Dextrose 2.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareLabeling Revision
Dianeal 137 W/ Dextrose 4.25% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareLabeling Revision
Dianeal Low Calcium W/ Dextrose 1.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareLabeling Revision
Dianeal Low Calcium W/ Dextrose 2.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareLabeling Revision
Dianeal Low Calcium W/ Dextrose 3.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareLabeling Revision
Dianeal Low Calcium W/ Dextrose 4.25% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareLabeling Revision
Dianeal Pd-1 W/ Dextrose 1.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareLabeling Revision
Dianeal Pd-1 W/ Dextrose 2.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareLabeling Revision
Dianeal Pd-1 W/ Dextrose 3.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareLabeling Revision
Dianeal Pd-1 W/ Dextrose 4.25% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareLabeling Revision
Dianeal Pd-2 W/ Dextrose 1.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareLabeling Revision
Dianeal Pd-2 W/ Dextrose 1.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareLabeling Revision
Dianeal Pd-2 W/ Dextrose 2.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareLabeling Revision
Dianeal Pd-2 W/ Dextrose 2.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareLabeling Revision
Dianeal Pd-2 W/ Dextrose 3.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareLabeling Revision
Dianeal Pd-2 W/ Dextrose 4.25% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareLabeling Revision
Dianeal Pd-2 W/ Dextrose 4.25% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareLabeling Revision
EstradiolestradiolFilm, Extended Release; TransdermalNovartisManufacturing Change or Addition
Imodium Multi-Symptom Reliefloperamide hydrochloride; simethiconeTablet;OralMcneil ConsManufacturing Change or Addition
KalydecoivacaftorTablet;OralVertex PharmsManufacturing Change or Addition
Namzaricdonepezil hydrochloride; memantine hydrochlorideCapsule, Extended Release;OralForest Labs LlcManufacturing Change or Addition
Oxycodone Hydrochlorideoxycodone hydrochlorideSolution;OralLehigh ValleyManufacturing Change or Addition
Premarinestrogens, conjugatedTablet;OralWyeth Pharms IncManufacturing Change or Addition
VarubirolapitantTablet;OralTesaro IncApproval
Vivelle-DotestradiolFilm, Extended Release;TransdermalNovartisManufacturing Change or Addition
Xigduo Xrdapagliflozin propanediol; metformin hydrochlorideTablet, Extended Release;OralAstrazeneca AbManufacturing Change or Addition
ZydeligidelalisibTablet;OralGilead Sciences IncManufacturing Change or Addition

 

August 31, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Antara (Micronized)fenofibrateCapsule;OralLupin AtlantisManufacturing Change or Addition
Fludeoxyglucose F18fludeoxyglucose f-18Injectable;IntravenousIba Molecular N AmApproval
Methadone Hydrochloridemethadone hydrochlorideTablet;OralAurolife Pharma LlcApproval
Premphase 14/14estrogens, conjugated; medroxyprogesterone acetateTablet;Oral-28Wyeth Pharms IncLabeling Revision
Premproestrogens, conjugated; medroxyprogesterone acetateTablet;Oral-28Wyeth Pharms IncLabeling Revision
RivastigminerivastigmineFilm, Extended Release;TransdermalAlvogen IncApproval
RivastigminerivastigmineSystem; TransdermalAlvogen IncApproval
Teflaroceftaroline fosamilPowder;Iv (Infusion)CerexaEfficacy Supplement with Clinical Data to Support
Teflaroceftaroline fosamilPowder;Iv (Infusion)CerexaLabeling Revision
Zoledronic Acidzoledronic acidInjectable;Iv (Infusion)Acs Dobfar Info SaManufacturing Change or Addition

 

August 28, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AravaleflunomideTablet;OralSanofi Aventis UsLabeling Revision
EmendaprepitantCapsule;OralMerckLabeling Revision
Erlotinib Hydrochlorideerlotinib hydrochlorideTablet;OralTeva Pharms UsaApproval
Escitalopram Oxalateescitalopram oxalateTablet;OralPrinston IncApproval
Glyxambiempagliflozin; linagliptinTablet;OralBoehringer IngelheimLabeling Revision
Janumetmetformin hydrochloride; sitagliptin phosphateTablet;OralMerck Sharp DohmeLabeling Revision
Janumet Xrmetformin hydrochloride; sitagliptin phosphateTablet, Extended Release;OralMerck Sharp DohmeLabeling Revision
Januviasitagliptin phosphateTablet;OralMerck Sharp DohmeLabeling Revision
Jentaduetolinagliptin; metformin hydrochlorideTablet;OralBoehringer IngelheimLabeling Revision
Kazanoalogliptin benzoate; metformin hydrochlorideTablet;OralTakeda Pharms UsaLabeling Revision
Kombiglyze Xrmetformin hydrochloride; saxagliptin hydrochlorideTablet, Extended Release;OralAstrazeneca AbLabeling Revision
Nesinaalogliptin benzoateTablet;OralTakeda Pharms UsaLabeling Revision
Onglyzasaxagliptin hydrochlorideTablet;OralAstrazeneca AbLabeling Revision
Osenialogliptin benzoate; pioglitazone hydrochlorideTablet;OralTakeda Pharms UsaLabeling Revision
PrinivillisinoprilTablet;OralMerckLabeling Revision
Raloxifene Hydrochlorideraloxifene hydrochlorideTablet;OralAurobindo Pharma LtdApproval
TegretolcarbamazepineTablet;OralNovartisLabeling Revision
TegretolcarbamazepineTablet, Chewable;OralNovartisLabeling Revision
TegretolcarbamazepineSuspension;OralNovartisLabeling Revision
Tegretol-XrcarbamazepineTablet, Extended Release;OralNovartisLabeling Revision
TradjentalinagliptinTablet;OralBoehringer IngelheimLabeling Revision

 

August 27, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Actimmuneinterferon gamma-1bVial; Single-UseVidara Therapeutics Research LtdLabeling Revision
Anoro Elliptaumeclidinium bromide; vilanterol trifenatatePowder;InhalationGlaxosmithklineManufacturing Change or Addition
Aptiomeslicarbazepine acetateTablet;OralSunovion Pharms IncEfficacy Supplement with Clinical Data to Support
Auryxiaferric citrateTablet;OralKeryx BiopharmsManufacturing Change or Addition
LinezolidlinezolidTablet;OralAlkem Labs LtdTentative Approval
LunestaeszopicloneTablet;OralSunovion Pharms IncManufacturing Change or Addition
MyaleptmetreleptinInjectable;InjectionAmylin Pharms LlcLabeling Revision
Mycaminemicafungin sodiumInjectable; InjectionAstellasManufacturing Change or Addition
Mycaminemicafungin sodiumInjectable;Iv (Infusion)AstellasManufacturing Change or Addition
RemicadeinfliximabVialCentocor IncLabeling Revision
RepathaevolocumabInjectable;InjectionAmgen IncApproval
Rimso-50dimethyl sulfoxideSolution;IntravesicalMylan InstitutionalManufacturing Change or Addition
Technelitetechnetium tc-99m sodium pertechnetate generatorSolution;IntravenousLantheus MedclManufacturing Change or Addition
TenorminatenololTablet;OralAlvogen Ipco SarlManufacturing Change or Addition

 

Page Last Updated: 09/03/2015
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