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UPDATE 1-Covidien says FDA extends review of opiod pain drug

Fri Nov 20, 2009 8:09am EST

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* FDA sets Feb. 22, 2010, as new action date

Stocks  |  Regulatory News  |  Healthcare

* Says FDA needs more time to review additional data

Nov 20 (Reuters) - Covidien Plc (COV.N) said U.S. health regulators extended the review period of its experimental opioid pain drug by three months to Feb. 22, 2010.

The decision by the U.S. Food and Drug Administration comes after Covidien submitted additional information, which the FDA determined to be a major amendment to the new drug application, the company said in a statement.

The date was extended as the FDA needed more time to review the application, Covidien said.

In June, Covidien acquired the U.S. rights to Neuromed's Exalgo, an extended-release formulation of the older pain drug hydromorphone.

Covidien is the largest U.S. supplier of controlled pain medications, based on the number of prescriptions, but they have all been generics.

Shares of the company closed at $45.13 Thursday on the New York Stock Exchange.

For alerts, double-click [ID:nWNAB8454] . (Reporting by Anand Basu in Bangalore; Editing by Unnikrishnan Nair)



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