Cadence Pharmaceuticals, Inc announced that the US Food and Drug Administration (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.
"We remain confident in our NDA submission and will continue to work closely with the FDA toward the potential approval of intravenous acetaminophen," said Ted Schroeder, president and chief executive officer of Cadence. "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.
IV acetaminophen is Cadence's proprietary intravenous formulation of acetaminophen. Acetaminophen is the most widely used medication for the treatment of pain and fever in the United States and is available in more than 600 combination and single-ingredient prescription and over-the-counter products.
Cadence Pharmaceuticals is a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting.