FDA Extends Review Of Cadence's IV Drug Acetavance
SAN DIEGO (AP) ¿ The Food and Drug Administration is extending its review of Cadence Pharmaceuticals Inc.'s painkiller Acetavance by three months until February 2010, the company said Friday.
The FDA said it needed more time to review pharmacology data, and is not asking for any additional information from Cadence.
The agency said it expects to make a decision on Acetavance, which is a form of acetaminophen given intravenously, by Feb. 12, 2010. A decision had been expected by Friday.
Cadence said it will work with the FDA as the data is evaluated, and said it will launch Acetavance in the second quarter if it is approved.
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