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Trials & Filings

Paladin PDUFA Date Extended

CMC changes lengthen review

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

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 as a major amendment filed during the final three months of the review and extended the PDUFA goal date. The FDA has not requested at this time any additional clinical studies prior to the revised action date.

Impavido has been granted orphan designation and fast-track status by the FDA, and has qualified for priority review.

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