Axcan Photofrin "approvable" for Barrett’s
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Axcan expects approval of Photofrin (porfimer sodium) for treatment of high grade dysplasia associated with Barrett's esophagus "in the next few months." FDA issued an "approvable" letter for the new indication Nov. 29. The firm has already submitted the major portion of data requested in the letter - two-year follow-up results - and expects to respond to FDA's other requests by the end of 200