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FDA Advisory Committee Recommends Approval of InterMune's Esbriet(R) (pirfenidone) for Idiopathic Pulmonary Fibrosis
Date:3/9/2010

IPF patients in the United States.

"We are pleased with the outcome of today's Advisory Committee meeting," said Dan Welch, Chairman, Chief Executive Officer and President of InterMune.  "We look forward to working closely with the FDA as review of the Esbriet NDA continues."

Though the Advisory Committee's recommendations are not binding, they will be considered as the FDA completes its review of the New Drug Application (NDA) for Esbriet.  Esbriet received Orphan Drug, Fast Track and Priority Review designations by the FDA.  Priority Review designation may be granted by the FDA to an NDA for drugs that have the potential to offer major advances in treatment, or provide a treatment where no adequate therapy exists.  A target date of May 4, 2010 has been set under the Prescription Drug User Fee Act (PDUFA).

Status of Esbriet (pirfenidone) in Europe

On March 2, 2010, InterMune announced that it had submitted a Marketing Authorization Application (MAA) t
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SOURCE InterMune, Inc.
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