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Pulmonary Fibrosis

Odds of Pirfenidone Approval in US

02/23/2010

Question:

Based on the Japanese and US data, should we expect FDA to approve the drug for use in the USA fir people with IPF?

Answer:

The FDA is currently reviewing the new drug application materials for pirfenidone and it is expected that they will render a decision on whether or not to approve it sometime in May 2009

For more information:

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Response by:

James N Allen, Jr, MD James N Allen, Jr, MD
Clinical Professor of Pulmonary, Allergy, Critical Care & Sleep Medicine
College of Medicine
The Ohio State University