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Pancrecarb Approval Status

Pancrecarb is a pancreatic enzyme replacement therapy for the treatment of Exocrine Pancreatic Insufficiency. In April 2004, the FDA determined that prescription Exocrine Pancreatic Insufficiency drug products are medically necessary and, accordingly, allowed the drug manufacturers four years (April 2008) to obtain approved new drug applications.

Development Status and FDA Approval Process for Pancrecarb

Oct 27, 2008Digestive Care, Inc. Announces the Complete Submission of the NDA for Pancrecarb (pancrelipase)
Jul  7, 2008Digestive Care, Inc. Announces the Filing of the First Module of NDA Submission for Pancrecarb (pancrelipase)

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