FDA establishes PDUFA date for ADVENTRX's Exelbine NDA review

Jan 20 2011

ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) announced today that the U.S. Food and Drug Administration (FDA) has established a Prescription Drug User Fee Act (PDUFA) date of September 1, 2011 for the review of the Exelbine (ANX-530) New Drug Application (NDA). The acceptance of the Exelbine NDA is the FDA's determination that the application is sufficiently complete to permit a substantive review, and the PDUFA date is the goal date for the FDA to complete its review of the NDA.  

"With a September PDUFA date established in the Day 74 letter from the FDA, we look forward to working closely with the Agency on moving Exelbine toward approval this year," said Brian M. Culley, Chief Executive Officer of ADVENTRX.

SOURCE ADVENTRX Pharmaceuticals, Inc.