Covidien Plc (COV) said that the FDA has set a new action date of March 1 to review the new drug application for Exalgo Extended-Release Tablets, (CII) from the previous action date of February 22.
The FDA extended the action date for Exalgo in order to allow more time for its review of pending NDAs following the agency's recent weather-related closure.
During the extended review process, Neuromed and Covidien will continue to collaborate to ensure any requests for information from the agency are addressed as quickly as possible.
Last November, the FDA already extended the review date of Exalgo by three months in order to gain time to review additional supplemental information.
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