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