Eurand NV, a Dutch manufacturer reports the U. S. Food and Drug Administration (FDA) has given its approval to Zenpep (pancrelipase) delayed-release capsules for treating a particular form of pancreatic disorder, which prevents people from digesting food properly.When the pancreas produces insufficient digestive enzymes, the result is exocrine pancreatic insufficiency (EPI), which could be a possible symptom of conditions that include cystic fibrosis and pancreatic cancer.Expected to be in US pharmacies sometime this year, Zenpep has been approved for sale as a delayed-release capsule available in four dosage strengths for treating infants, toddlers, adolescents, and adults. Pancrelipase (Zenpep), is the first pancreatic enzyme product for patients with cystic fibrosis and other conditions evaluated for both adults and children aged 1 to 12.Some of the side-effects reported during clinical testing of Zenpep include, gastro-intestinal problems, abdominal pain, flatulence, headache, cough, weight loss, early satiety, and contusion.FDA plans to have all similar products undergo the drug approval process by April 2010, formally approving the first of these treatments i. e. Solvay Pharmaceuticals' Creon in May, while there are at least three other manufacturers who have produced similar drugs.
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