FDA extends Cadence drug review

Saying it needs more time to evaluate pharmacological data, the FDA has extended the review period for Cadence Pharmaceuticals' Acetavance until February 2010. The original PDUFA data was today. Fortunately for Cadence, the agency isn't asking for any additional data to complete its assessment of Acetavance (intravenous acetaminophen), a treatment for acute pain and fever in adults and children.

"We remain confident in our NDA submission and will continue to work closely with the FDA toward the potential approval of intravenous acetaminophen," says 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."

- see the release from Cadence [1]
- read the brief [2]

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Cadence's Acetavance gets priority review [3]
Cadence files NDA for Acetavance [4]
Cadence Pharma pockets $86M in placement [5]