Exocrine Pancreatic Insufficiency Drug Products; Extension to Obtain Marketing Approval

Resumo

The Food and Drug Administration (FDA) is announcing that it intends to continue to exercise enforcement discretion to ensure the continued availability of exocrine pancreatic insufficiency drug products after April 28, 2008. FDA intends to exercise its enforcement discretion with respect to unapproved pancreatic enzyme drug products until April 28, 2010, if the manufacturers have investigational new drug applications (INDs) on active status on or before April 28, 2008, and have submitted new drug applications (NDAs) on or before April 28, 2009. FDA is granting this extension to ensure the availability of exocrine pancreatic insufficiency drug products during the additional time needed by manufacturers to obtain marketing approval.