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Ofev Approval History

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; Sclerosis-Associated Interstitial Lung Disease

Ofev (nintedanib) is a small molecule tyrosine kinase inhibitor (TKI) indicated for the treatment of idiopathic pulmonary fibrosis, and systemic sclerosis-associated interstitial lung disease (SSc-ILD).

Development History and FDA Approval Process for Ofev

DateArticle
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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