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Esbriet Approval History

FDA Approved: Yes (First approved October 15, 2014)
Brand name: Esbriet
Generic name: pirfenidone
Dosage form: Capsules
Company: InterMune, Inc.
Treatment for: Idiopathic Pulmonary Fibrosis

Esbriet (pirfenidone) is a TGF-beta synthesis inhibitor for the treatment of patients with idiopathic pulmonary fibrosis (IPF).

Development History and FDA Approval Process for Esbriet

DateArticle
Oct 15, 2014Approval FDA Approves Esbriet (pirfenidone) for Idiopathic Pulmonary Fibrosis
Jul 17, 2014InterMune Receives FDA Breakthrough Therapy Designation for Pirfenidone, an Investigational Treatment for IPF
May 27, 2014InterMune Announces Resubmission Of NDA For Pirfenidone For The Treatment Of Patients With IPF
May 16, 2014InterMune Announces Expanded Access Program for Pirfenidone to Treat Idiopathic Pulmonary Fibrosis (IPF) in the United States
Feb 25, 2014InterMune Reports Phase 3 ASCEND Trial Results of Pirfenidone in Idiopathic Pulmonary Fibrosis (IPF)
May  7, 2010Coalition for Pulmonary Fibrosis Responds to News of Further Review of Pirfenidone By FDA
May  5, 2010InterMune Receives FDA Complete Response Letter on Esbriet (pirfenidone) New Drug Application
Mar 10, 2010FDA Advisory Committee Recommends Approval of InterMune's Esbriet (pirfenidone) for Idiopathic Pulmonary Fibrosis
Mar  5, 2010InterMune Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on Pirfenidone
Jan  6, 2010FDA Grants Priority Review of Pirfenidone NDA for the Treatment of Patients With IPF
Nov  4, 2009InterMune Announces Submission of NDA for Pirfenidone for the Treatment of Patients with IPF

Further information

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