Drugs@FDA: FDA-Approved Drugs

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Original NDA and Original BLA Approvals
December 2017

This report includes NDAs [including NDAs for new molecular entities (NMEs)] and BLAs (including new biological products) approved for the first time during the selected month. Original BLA/NDA approvals by CBER are not included in Drugs@FDA. This report does not include approved NDA or BLA supplements, approved ANDAs, or tentatively approved ANDAs/NDAs.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on August 15, 2020.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
12/01/2017 OGIVRI
BLA #761074
TRASTUZUMAB-DKST MYLAN GMBH
12/05/2017 LONHALA MAGNAIR KIT
NDA #208437
GLYCOPYRROLATE Type 3 - New Dosage Form and Type 4 - New Combination Standard SUNOVION RESP
12/05/2017 OZEMPIC
NDA #209637
SEMAGLUTIDE Type 1 - New Molecular Entity Standard NOVO
12/08/2017 SINUVA
NDA #209310
MOMETASONE FUROATE Type 3 - New Dosage Form Standard INTERSECT ENT INC
12/11/2017 XEPI
NDA #208945
OZENOXACIN Type 1 - New Molecular Entity Standard FERRER INTERNACIONAL
12/11/2017 ADMELOG
BLA #209196
INSULIN LISPRO SANOFI-AVENTIS US
12/11/2017 ADMELOG SOLOSTAR
BLA #209196
INSULIN LISPRO SANOFI-AVENTIS US
12/13/2017 IXIFI
BLA #761072
INFLIXIMAB-QBTX PFIZER INC
12/14/2017 ALTAFLUOR BENOX
NDA #208582
BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM Type 4 - New Combination Priority ALTAIRE PHARMS INC
12/14/2017 ESKATA
NDA #209305
HYDROGEN PEROXIDE Type 5 - New Formulation or New Manufacturer Standard ACLARIS
12/14/2017 GOPRELTO
NDA #209963
COCAINE HYDROCHLORIDE Type 5 - New Formulation or New Manufacturer Standard GENUS LIFESCIENCES
12/17/2017 MEDICAL AIR, USP
NDA #211270
MEDICAL AIR Medical Gas Unknown LINDE GAS PUERTO RICO INC
12/18/2017 RHOPRESSA
NDA #208254
NETARSUDIL MESYLATE Type 1 - New Molecular Entity Standard AERIE PHARMS INC
12/19/2017 PREXXARTAN
NDA #209139
VALSARTAN Type 3 - New Dosage Form Standard CARMEL BIOSCIENCES
12/19/2017 STEGLATRO
NDA #209803
ERTUGLIFLOZIN Type 1 - New Molecular Entity Standard MERCK SHARP DOHME
12/19/2017 STEGLUJAN
NDA #209805
ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE Type 4 - New Combination Standard MERCK SHARP DOHME
12/19/2017 SEGLUROMET
NDA #209806
ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE Type 4 - New Combination Standard MERCK SHARP DOHME
12/20/2017 MACRILEN
NDA #205598
MACIMORELIN ACETATE Type 1 - New Molecular Entity Standard NOVO
12/21/2017 BIVALIRUDIN IN 0.9% SODIUM CHLORIDE
NDA #208374
BIVALIRUDIN Type 5 - New Formulation or New Manufacturer Standard BAXTER HLTHCARE CORP
12/21/2017 SIKLOS
NDA #208843
HYDROXYUREA Type 3 - New Dosage Form Priority ADDMEDICA SAS
12/21/2017 GIAPREZA
NDA #209360
ANGIOTENSIN II ACETATE Type 1 - New Molecular Entity Priority LA JOLLA PHARMA
12/22/2017 LUMIFY
NDA #208144
BRIMONIDINE TARTRATE Type 5 - New Formulation or New Manufacturer Standard BAUSCH AND LOMB INC

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