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Product Update
May 6, 2010
Dear Healthcare Provider:
Axcan Pharma US, Inc., (“Axcan” or the “Company”) announced today that the U.S. Food and Drug Administration (“FDA”) has issued a complete response letter regarding its New Drug Application (“NDA”) for ULTRASE® MT in the treatment of exocrine pancreatic insufficiency.
We will respond to the FDA’s letter as quickly as possible. The FDA has not requested that new clinical studies be conducted on ULTRASE® MT as a prerequisite for approval. Requests raised in the letter primarily relate to certain chemistry, manufacturing and control data, or CMC, work requirements. We will continue to work closely with the FDA to address outstanding questions as soon as possible. While Axcan is confident that ULTRASE® MT will ultimately obtain NDA approval, no further guidance can be given on when that might occur.
Although we are very disappointed that ULTRASE® MT has not yet been approved by the Prescription Drug User Fee Act (“PDUFA”) date, we continue to work with the FDA, devoting substantial resources to gain NDA approval. This complete response letter combined with our recent interaction with the FDA gives us a clearer understanding of remaining steps to be accomplished before we obtain FDA approval.
Please note that the FDA is not requiring manufacturers to recall products currently in the market. Therefore patients do not need to return medication. ULTRASE® MT may continue to be available for a period of time until inventory levels at pharmacies are depleted. As with all medications, patients are advised to contact their health care providers, if they have any questions.
We want to assure both patients and healthcare providers that Axcan is committed to meeting the needs of those suffering from exocrine pancreatic insufficiency, as we have done for the past 18 years.
If you or your patients have any questions or concerns, please click here, where further information is available. You can also contact us by phone at 1-877-338-0081.
Sincerely,
Frank Verwiel, M.D.
President and Chief Executive Officer
