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Esbriet Approval Status

Esbriet (pirfenidone) is an orally active small molecule drug that may inhibit collagen synthesis, down regulate production of multiple cytokines and block fibroblast proliferation and stimulation in response to cytokines. Pirfenidone is in development for the treatment of patients with idiopathic pulmonary fibrosis (IPF).

FDA Approval Status for Esbriet

DateArticle
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

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