US FDA grants priority review for Mallinckrodt's pain relief drug
The US Food and Drug Administration has accepted and granted a priority review for the New Drug Application for MNK-795 from US drug manufacturer Mallinckrodt (NYSE: MNK).
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 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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