The FDA has notified Paladin Labs that it is extending the Prescription Drug User Fee Act (PDUFA) goal date for its NDA for Impavido (miltefosine) for the treatment of cutaneous, mucosal, and visceral leishmaniasis from December 19, 2013 to March 19, 2014. During the course of recent discussions with the FDA, Paladin submitted revisions regarding chemistry, manufacturing and control (CMC) details and other aspects related to the proposed label. The FDA determined that this submission qualified ...