Treats idiopathic pulmonary fibrosis (IPF). NDA 205832, held by Boehringer Ingelheim. Nintedanib Esylate.
As of Nov 13, 2026, NDA 205832 (Ofev), held by Boehringer Ingelheim, was first approved by FDA on Oct 15, 2014, with 13 approved supplements and 0 published complete response letters.
OFEV is a kinase inhibitor indicated in adults for: Treatment of idiopathic pulmonary fibrosis (IPF) Treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype Slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) 1.1 Idiopathic Pulmonary Fibrosis OFEV is indicated for the treatment of adults with idiopathic pulmonary fibrosis (IPF). 1.2 Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype OFEV is indicated for the treatment of adults with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. 1.
| Mar 9, 2020 | Supplement 13Efficacy (new indication or use) · Priority review | Approved | |
| Sep 6, 2019 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Oct 15, 2014 | Original applicationNew molecular entity · Priority review | Approved |
| OfevEQ 100MG BASE · capsule;oral | Nintedanib Esylate | RxReference drug |
| OfevEQ 150MG BASE · capsule;oral | Nintedanib Esylate | RxReference drug |
| Oct 11, 2024 | Supplement 28Labeling · Standard review | Approved | |
| Jun 18, 2024 | Supplement 27Labeling · Standard review | Approved | |
| Jan 13, 2022 | Supplement 16Labeling · Standard review | Approved | |
| Oct 28, 2020 | Supplement 14Labeling · Standard review | Approved | |
| Mar 9, 2020 | Supplement 13Efficacy (new indication or use) · Priority review | Approved | |
| Sep 6, 2019 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Nov 9, 2018 | Supplement 10Labeling · Standard review | Approved | |
| Jan 29, 2018 | Supplement 9Labeling · Standard review | Approved | |
| Dec 13, 2017 | Supplement 7Labeling · Standard review | Approved | |
| Aug 4, 2017 | Supplement 5Labeling · Standard review | Approved | |
| Feb 9, 2017 | Supplement 4Labeling · Standard review | Approved | |
| Jun 16, 2016 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Feb 4, 2016 | Supplement 1Labeling · Standard review | Approved | |
| Oct 15, 2014 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
