U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Original NDA and Original BLA Approvals
February 2018

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 May 10, 2024.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
02/05/2018 SYMFI LO
NDA #208255		 EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE Type 3 - New Dosage Form Priority MYLAN
02/07/2018 BIKTARVY
NDA #210251		 BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE Type 1 - New Molecular Entity and Type 4 - New Combination Priority GILEAD SCIENCES INC
02/08/2018 RADIOGENIX SYSTEM
NDA #202158		 TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR Type 5 - New Formulation or New Manufacturer Standard NORTHSTAR MEDICAL
02/09/2018 DEXYCU KIT
NDA #208912		 DEXAMETHASONE Type 5 - New Formulation or New Manufacturer Standard EYEPOINT PHARMS
02/09/2018 DOLUTEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDE
NDA #210237		 DOLUTEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDE Type 4 - New Combination Priority MYLAN LABS
02/12/2018 SYMDEKO (COPACKAGED)
NDA #210491		 IVACAFTOR; IVACAFTOR, TEZACAFTOR Type 1 - New Molecular Entity and Type 4 - New Combination Priority VERTEX PHARMS INC
02/14/2018 ERLEADA
NDA #210951		 APALUTAMIDE Type 1 - New Molecular Entity Priority JANSSEN BIOTECH
02/16/2018 OSMOLEX ER
NDA #209410		 AMANTADINE HYDROCHLORIDE Type 3 - New Dosage Form Standard ADAMAS OPERATIONS
02/16/2018 IMBRUVICA
NDA #210563		 IBRUTINIB Type 3 - New Dosage Form Priority PHARMACYCLICS LLC
02/22/2018 LUSDUNA
NDA #209764		 INSULIN GLARGINE Type 5 - New Formulation or New Manufacturer Standard MERCK SHARP DOHME
02/23/2018 EFAVIRENZ
NDA #205389		 EFAVIRENZ Type 5 - New Formulation or New Manufacturer Standard MICRO LABS LTD INDIA
02/23/2018 APADAZ
NDA #208653		 ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE Type 4 - New Combination Priority ZEVRA THERAP
02/26/2018 VERZENIO
NDA #208855		 ABEMACICLIB Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval Priority ELI LILLY AND CO
02/28/2018 CIMDUO
NDA #022141		 LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE Type 4 - New Combination Priority MYLAN LABS LTD
02/28/2018 ZTLIDO
NDA #207962		 LIDOCAINE Type 5 - New Formulation or New Manufacturer Standard SCILEX PHARMS
Back to Top