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 the active ingredient, as well as deficiencies identified in an inspection of the manufacturing facility. Axcan said it is in ongoing discussion with the agency and is continuing to work with the undisclosed manufacturer of the active ingredient to address remaining issues. In May, FDA issued a complete response letter for Ultrase citing manufacturing and control process deficiencies at the manufacturer.

Axcan withdrew Ultrase from the market in April because it did not receive approval for the product under new FDA guidelines requiring NDA approval for pancreatic enzyme replacement therapies. The agency issued the guidelines in 2004 requiring that all pancreatic enzyme product (PEP) manufacturers obtain approval by April 2010, but would permit manufacturers to market unapproved products until the deadline. ...