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 |