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12:00 AM
 | 
Dec 06, 2010
 |  BC Week In Review  |  Clinical News  |  Regulatory

Ultrase regulatory update

FDA issued a complete response letter for an NDA from Axcan for Ultrase to treat exocrine pancreatic insufficiency (EPI). According to Axcan, the agency requested that the company address unresolved deficiencies raised with respect to the manufacturing and control processes of the manufacturer of...

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