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- Title
First FDA-approved pancrelipase product may mark new era for providers, patients.
- Authors
Traynor, Kate
- Abstract
The article reports that the U.S. Food and Drug Administration (FDA) has approved a reformulated version of Solvay Pharmaceutical Inc.'s delayed-release pancrelipse product. It notes that the drug is indicated for the treatment of exocrine pancreatic insufficiency in children and adults. It also clarifies that the FDA in 2004 has required formal agency approval for new pancreatic enzyme products.
- Subjects
UNITED States; DRUG approval; UNITED States. Food &; Drug Administration; SOLVAY Pharmaceuticals Inc.; LIPASES; DIGESTIVE enzymes
- Publication
American Journal of Health-System Pharmacy, 2009, Vol 66, Issue 12, p1066
- ISSN
1079-2082
- Publication type
Article
- DOI
10.2146/news090052