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Ofev Approval History

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

Ofev (nintedanib) is a small molecule tyrosine kinase inhibitor (TKI) for the treatment of idiopathic pulmonary fibrosis.

Development History and FDA Approval Process for Ofev

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

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