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Aptalis Pharma receives FDA nod for Zenpep new strength

Aptalis Pharma has received the US Food and Drug Administration (FDA) approval for the new dosage strength of Zenpep (pancrelipase) delayed-release capsules.

Aptalis Pharma will offer Zenpep in 25,000 units of lipase for pateints with exocrine pancreatic insufficiency (EPI) caused by CF or other conditions.

Aptalis Pharma president and CEO Frank Verwiel said that added to the recent FDA approval of the 3,000-unit dose, ZENPEP offers physicians and their patients the range of dosing options, including the lowest and highest doses available, of any FDA-approved pancreatic enzyme product.

"We believe the broad range of ZENPEP strengths can provide added convenience by helping patients reduce the number of capsules they take with every meal, while the precise dosing can aid in the management of their EPI," Verwiel said.