Drugs@FDA: FDA Approved Drug Products

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Original New Drug Application
NDA and BLA) Approvals
December 2017

This report lists all applications approved for the first time during the selected month. It includes New Molecular Entities (NMEs) and new biologics. * It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date. This page shows current information for the products listed.

Click on the Application Number to see all drug details, including the full approval history.* Not all biologics are in Drugs@FDA.

This report was produced on November 22, 2019.

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
NDA #209196
INSULIN LISPRO Type 5 - New Formulation or New Manufacturer Standard SANOFI-AVENTIS US
12/11/2017 ADMELOG SOLOSTAR
NDA #209196
INSULIN LISPRO Type 5 - New Formulation or New Manufacturer Standard 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 DIMESYLATE 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
* NDA Submission Classifications
For details, see FDA/CDER MAPP 5018.2
Classification Meaning
Type 1 New molecular entity
Type 2 New active ingredient
Type 3 New dosage form
Type 4 New combination
Type 5 New formulation or other differences
Type 6 New indication or claim, same applicant [no longer used]
Type 7 Previously marketed but without an approved NDA
Type 8 Rx to OTC
Type 9 New indication or claim, drug not to be marketed under type 9 NDA after approval
Type 10 New indication or claim, drug to be marketed under type 10 NDA after approval
Type 1/4 Type 1, New molecular entity, and Type 4, New combination
Type 2/3 Type 2, New active ingredient, and Type 3, New dosage form
Type 2/4 Type 2, New active ingredient and Type 4, New combination
Type 3/4 Type 3, New Dosage Form, and Type 4, New combination
Meaning
Priority: Review designation assigned to applications for drugs that treat serious conditions and provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions compared to available therapies
Standard: Review designation assigned to applications for drugs that do not meet the priority review designation criteria

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