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May 27, 2014
07:03 EDTITMNInterMune announces resubmission of NDA for Perfernidone
InterMune announced that it has resubmitted its pirfenidone New Drug Application to the FDA in response to a Complete Response Letter received in May 2010. Pirfenidone is being developed for the treatment of adult patients with idiopathic pulmonary fibrosis. Under the Prescription Drug User Fee Act, the FDA has 74 days after receipt of an NDA to evaluate the submission in order to determine if it is sufficiently complete. If in this 74-day period the FDA determines that the submission is complete, the review clock will be deemed to have started as of the date that the resubmission was initially received by the FDA. As the resubmission of an efficacy supplement, the submission of the ASCEND data represents a Class 2 resubmission that has a target FDA review of six months under PDUFA V.
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