Ofev FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 28, 2021.

FDA Approved: Yes (First approved October 15, 2014)
Brand name: Ofev
Generic name: nintedanib
Dosage form: Capsules
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Idiopathic Pulmonary Fibrosis; Interstitial Lung Disease

Ofev (nintedanib) is a small molecule tyrosine kinase inhibitor (TKI) indicated 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).

Development timeline for Ofev

Date	Article
Mar 9, 2020	Approval FDA Approves Ofev (nintedanib) as First Treatment for Chronic Fibrosing Interstitial Lung Diseases (ILDs) with a Progressive Phenotype
Sep 6, 2019	Approval FDA Approves Ofev (nintedanib) for Interstitial Lung Disease Associated with Systemic Sclerosis or Scleroderma (SSc-ILD)
Oct 15, 2014	Approval FDA Approves Ofev (nintedanib) for Idiopathic Pulmonary Fibrosis
Jul 16, 2014	Boehringer Ingelheim’s Investigational Therapy Nintedanib Receives FDA Breakthrough Therapy Designation
Jul 2, 2014	U.S. FDA Accepts NDA Filing for Boehringer Ingelheim’s Nintedanib for Idiopathic Pulmonary Fibrosis

Further information

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Medical Disclaimer

Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

Ofev FDA Approval History

Development timeline for Ofev

See also

Further information