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Friday, December 6, 2013
Dear Dr. James, thank you very much for answering question about pirfenidone. How long approximately may take FDA approval? Also, do we need any kind of prescription to buy drugs in Japan or in Europe? As you understand, this is lifesaving questions. Thanks.
The time it takes the FDA to approve a new drug can vary depending on whether the FDA review requires additional information or additional testing. In general, the process takes 10-12 months, but can on occasion take several years. I am not aware of the process that is involved in obtaining prescriptions from Japan. Pirfenidone is being developed by the Shionogi company in Japan and according to their website, they have submitted a new drug application for pirfenidone in March, 2007. I am not aware that it has been approved yet for general prescription in Japan, however.
James N Allen, Jr, MD
Clinical Professor of Pulmonary, Allergy, Critical Care & Sleep Medicine
College of Medicine
The Ohio State University