Cadence Pharmaceuticals Inc. (CADX) said Friday that the FDA has extended the review of its proposed intravenous pain killer, Acetavance or IV acetaminophen, by three months. The extended Prescription Drug User Fee Act or PDUFA goal date is February 12, 2010. Following the news, the company's stock lost more than 7% in the intra-day trading.
The FDA designated one of Cadence's submissions to the NDA, which contained additional clinical pharmacology data, 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 has not requested any other information at this time, the company noted.
Acetavance 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 acquired the exclusive rights to the proprietary intravenous form of acetaminophen in the United States and Canada in 2006 from Bristol-Myers Squibb Co. (BMY), which markets the product as Perfalgan in Europe and other parts of the world.
Cadence submitted its New Drug Application for Acetavance in May and was granted a priority review with the FDA action date set for November 13.
If approved, Acetavance would have been the first new intravenous analgesic approved in the United States in more than 20 years and the only approved intravenous agent for the treatment of fever in the United States.
Cadence was optimistic that it would gain FDA approval for Acetavance and it has even hired its sales management team for the potential launch of the drug and is currently recruiting sales representatives contingent on FDA approval.
Commenting on the FDA's decision today, Ted Schroeder, president and chief executive officer of Cadence, said, "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."
CADX is currently trading at $9.00, down 55 cents or 5.76%.
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