Covidien's Exalgo NDA: FDA sets new PDUFA action date

Covidien (NYSE:COV) today announced that the U.S. Food and Drug Administration (FDA) has set a new action date of March 1, 2010, under the Prescription Drug User Fee Act (PDUFA) for the review of the New Drug Application (NDA) for Exalgo™ (hydromorphone HCl) Extended-Release Tablets, (CII).

The latest rescheduling of the action date for Exalgo is the result of the FDA’s decision to allow more time for its review of pending NDAs following the agency’s recent weather-related closure. Please see http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm200361.htm for the FDA’s press release on the subject.

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.

Covidien is the largest supplier of controlled pain medications in the United States, based on number of prescriptions. Its development partner, Neuromed Pharmaceuticals Ltd., a wholly owned subsidiary of CombinatoRx, Incorporated, develops novel drug candidates with a focus on the treatment of pain and inflammation.

In June 2009, the companies announced that Mallinckrodt Inc., a Covidien company, had entered into an asset purchase agreement with Neuromed for the U.S. commercialization rights to Exalgo. Under the agreement, Covidien is responsible for all commercialization activities for Exalgo, including marketing, sales and all post-approval FDA regulatory filings. Neuromed acquired the U.S. marketing rights to Exalgo from ALZA Corporation in April 2007. CombinatoRx and Neuromed merged on December 21, 2009.

SOURCE Covidien