BRIEF—FDA sets date for review of Mallinckrodt's Roxicodone

Mallinckrodt, a leading global specialty pharmaceutical company, today announced that the US Food and Drug Administration has confirmed it will hold a joint meeting of its Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee on November 14, 2018.

The Committees will assess the 505(b)2 New Drug Application submission for MNK-812, Mallinckrodt's abuse-deterrent formulation of immediate-release, single-entity oxycodone tablets with a proposed indication for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Mallinckrodt is advancing this reformulation of Roxicodone (oxycodone hydrochloride tablets USP) with properties designed to deter intravenous and intranasal abuse.

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 16, 2018, to complete its review of Mallinckrodt's product.