Pancrecarb Approval Status
- FDA approved: No
- Brand name: Pancrecarb
- Generic name: pancrelipase
- Company: Digestive Care, Inc.
- Treatment for: Pancreatic Exocrine Dysfunction
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.
FDA Approval Status for Pancrecarb
|Oct 27, 2008||Digestive Care, Inc. Announces the Complete Submission of the NDA for Pancrecarb (pancrelipase)|
|Jul 7, 2008||Digestive Care, Inc. Announces the Filing of the First Module of NDA Submission for Pancrecarb (pancrelipase)|
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