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Mallinckrodt Inc. New Drug Application Granted Priority Review by FDA


7/29/2013 9:44:49 AM

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HAZELWOOD, Mo.--(BUSINESS WIRE)--Mallinckrodt (NYSE: MNK) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for MNK-795 and granted priority review. MNK-795 is a controlled-release oral formulation of oxycodone and acetaminophen that has been studied for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. FDA priority review is a defined NDA review process used for drugs that, if approved, offer significant improvements in the safety or effectiveness of the treatment when compared to standard applications.

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