Covidien says FDA extends Exalgo review

AP News
Posted: Nov 20, 2009 10:56 AM

Health care company Covidien PLC said Friday the Food and Drug Administration will take longer than expected to review the potential opioid pain drug Exalgo.

The agency said it is delaying a decision on the treatment by three months, to Feb. 22. The FDA was scheduled to make a decision by Nov. 22, but the company sent in additional information on the drug candidate. That prompted the three-month extension by the agency.

In June, Ireland-based Covidien bought the rights to Exalgo from Neuromed Pharmaceuticals Ltd. for an undisclosed amount.

Shares of Covidien fell 14 cents to $45 in morning trading.