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
|Oct 15, 2014|| 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|
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