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FDA declines to approve reformulated Mallinckrodt opioid


(Reuters) – Mallinckrodt Plc said on Wednesday the U.S. Food and Drug Administration declined to approve an abuse-deterrent version of its opioid painkiller Roxicodone.

Certain parts of the company’s application need further evaluation, Mallinckrodt said, citing the FDA.

The treatment is a reformulated version of Mallinckrodt’s commonly abused painkiller Roxicodone, intended to make the drug less desirable and more difficult to be abused by snorting or injecting.

The decision comes after an advisory panel to the FDA voted 10-7 in favor of the drug, saying it should be labeled as abuse deterrent only by the nasal route.

Reporting by Tamara Mathias in Bengaluru; Editing by Saumyadeb Chakrabarty

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