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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

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

Further information

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