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Mallinckrodt Granted Priority Review for Pain Drug

Mallinckrodt (NYSE: MNK) announced Monday that the FDA has accepted for filing the New Drug Application for MNK-795 and granted priority review.

The drug, MNK-795 is an oral formulation of oxycodone and acetaminophen indicated for the treatment of moderate to severe acute pain. 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.

“Despite the number of available pain medications, patients continue to experience unresolved pain and lack treatment options that offer fast-acting and long-lasting relief. We are pleased the FDA granted priority review designation,” said Mark Trudeau, President and Chief Executive Officer, Mallinckrodt Pharmaceuticals. “Mallinckrodt has unique capabilities in complex formulations such as MNK-795 and this marks an important milestone for us as our first NDA acceptance as an independent specialty pharmaceutical company.”

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Disclosure: At the time of this writing, the author had no position in the company mentioned.

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