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)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.