Post the announcement by drug-maker Cadence Pharmaceuticals Inc., that the Food and Drug Administration has delayed the review of its experimental painkiller Acetavance by three months, and an approval is now expected in February 2010, the firm's shares fell by as much as 10% to trade at $8.61.
According to the FDA, the agency is not asking for any additional information from Cadence and just needs some more time to properly review the drug. An earlier decision, which was expected by Friday, was to decide the stance of Acetavance, which is a form of acetaminophen given intravenously.
In July, the drug had received a priority review status, and the FDA is looking to approve its release as soon as possible, but only after all necessary criteria have been met.
The drug maker has said that it will fully co-operate with the FDA, given any information that is needed and market the medicine by next year's second quarter if an approval is given in February. "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", Chief Executive Ted Schroeder said in a statement.
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