PDUFA date set for pirfenidone NDA

|By:, SA News Editor

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.