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PDUFA date set for pirfenidone NDA

  • The FDA acknowledges the receipt of Intermune's (ITMN) resubmitted NDA for pirfenidone. The PDUFA date in November 23, 2014. The agency sent the company a CRL in May 2010 recommending an additional Phase 3 clinical trial to support the efficacy of the product. Pirfenidone is being developed as a treatment for idiopathic pulmonary fibrosis in adult patients.
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