FDA Extends NDA Review For Intravenous Acetaminophen

Cadence Pharmaceuticals has announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date for its priority review of the New Drug Application (NDA) for intravenous (IV) acetaminophen by three months. The extended PDUFA goal date is February 12, 2010.

Ted Schroeder, president and chief executive officer of Cadence, said: “We remain confident in our NDA submission and will continue to work closely with the FDA toward the potential approval of intravenous acetaminophen. We are now planning for a launch early in the second quarter of 2010 and continuing to move forward with all of our commercial readiness activities, including recruitment of our sales force.”

The FDA designated one of Cadence’s submissions to the NDA, which contained additional clinical pharmacology data requested by the agency during the review process, as a major amendment. The FDA has the option to extend the PDUFA goal date when a sponsor submits a major amendment to an NDA within three months of the PDUFA goal date to provide time to complete the review. The FDA is not requesting any other information at this time.