Eurand N.V. secures FDA approval for ZENPEP for EPI
Mon. August 31, 2009; Posted: 04:30 AM
Aug 31, 2009 (M2 EQUITYBITES via COMTEX) --
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PowerRating -- Pharmaceutical company Eurand N.V. (NASDAQ:EURX) declared on Friday the
grant of approval from the US Food and Drug Administration (FDA) for
its New Drug Application (NDA) for ZENPEP (pancrelipase)
Delayed-Release Capsules for the treatment of exocrine pancreatic
insufficiency (EPI) in patients with cystic fibrosis or other
conditions.
The company said that ZENPEP is the only FDA-approved pancreatic enzyme
product (PEP) that has been evaluated in clinical studies in adults and
children, including children from one to 12 years old, and will offer
four dosage strengths to meet the varied needs of infants, toddlers,
adolescents and adults with EPI.
ZENPEP is planned to be introduced in the US market in the fourth
quarter of 2009.
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