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 Exocrine Pancreatic Insufficiency Drug Products

FDA announces that all exocrine pancreatic insufficiency drug products are "new drugs" and therefore require FDA-approved new drug applications (NDAs) as a condition of legal marketing. FDA has decided to require companies to submit marketing applications after reviewing data that showed variations in the effectiveness and manufacturing quality of the currently marketed (without NDAs) pancreatic extract drug products. These variations might significantly affect the drugs’ efficacy and could lead to over-or under-dosing. Companies that market pancreatic extract drug products have four years to obtain approved new drug applications.

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Date created: April 27, 2004, updated April 14, 2006

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