Pancreatic Enzyme ZENPEP™ Gets FDA Approval
September 1, 2009
The U.S. Food and Drug Administration (FDA) has approved ZENPEP™ (pancrelipase), a pancreatic enzyme replacement therapy.
Pancreatic enzymes are an essential treatment of cystic fibrosis. They help people with the disease absorb nutrients.
The FDA is requiring all pancreatic enzyme replacement products on the market to be reformulated and undergo clinical testing. ZENPEP, developed by Eurand, is the second enzyme therapy to be granted approval.
“The Cystic Fibrosis Foundation encouraged the FDA to mandate that pancreatic enzymes be reformulated and retested. The process will ensure that all of these products are of the highest quality,” said Robert J. Beall, Ph.D., president and chief executive officer of the Cystic Fibrosis Foundation. “Pancreatic enzymes approved through this process will help ensure that CF patients receive products that are documented to be safe and effective.”
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