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NetWellness provides the highest quality health information and education services created and evaluated by faculty of our partner universities.
Wednesday, July 9, 2008
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NetWellness provides the highest quality health information and education services created and evaluated by faculty of our partner universities.
Wednesday, July 9, 2008
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Pulmonary Fibrosis |
Pulmonary fibrosis05/06/2008 10:36AM |
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.
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James N. Allen, Jr., MD Professor - Clinical Pulmonary, Allergy, Critical Care & Sleep Medicine Department of Internal Medicine College of Medicine The Ohio State University |
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