FDA Approves Eurand Drug – Analyst Blog
Zacks Market Commentaries (August 31st, 2009) Writes:
On Friday, the U.S. Food and Drug Administration (FDA) approved Eurand N.V.'s (EURX) New Drug Application for its pancreatic enzyme product (PEP) Zenpep. The product targets a condition where insufficient secretion of enzymes by the pancreas hampers digestion of food. This phenomenon, known as exocrine pancreatic insufficiency (EPI), causes malnutrition, impaired growth in children, compromised immune response and shortened life expectancy. EPI is very common in cystic fibrosis patients. Cystic fibrosis causes life-threatening lung infections and serious digestive complications. Zenpep, which improves digestion and absorption by replacing the missing enzymes, is the only FDA-approved PEP to be tested in adults and children below 12 years of age. The approval of Zenpep is a major milestone for EPI patients. The drug would enable doctors to fine tune treatment regimens to achieve optimal symptom control with improved dosing precision thereby reducing pill burden. Previously, PEPs were not regulated and
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