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FDA Gives Priority Review to Depomed, Mallinckrodt Painkiller

NEW YORK (AP) -- Depomed Inc. and Mallinckrodt PLC said Monday that the Food and Drug Administration plans to conduct a faster review of their pain drug MNK-795.

The companies said the FDA will run a priority review of the drug, which means the agency expects to make a decision on their application in six months instead of the usual 10 months.

MNK-795 is a form of oxycodone and acetaminophen for moderate to severe acute pain. It includesDepomed's Acuform technology, which is designed to improve existing oral medications by allowing for their extended, controlled release to the upper gastrointestinal tract.

The FDA's acceptance of the application triggers a $5 million payment to Depomed by Mallinckrodt. Depomed said it will get another payment if MNK-795 is approved, and it will get royalty payments on sales.


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