Actavis gains FDA approval for generic version of Mallinckrodt's Exalgo

DUBLIN — Actavis on Tuesday announced that it has received final approval from the Food and Drug Administration on its abbreviated new drug application for a generic version of Mallinckrodt's Exalgo (hydromorphone hydrochloride extended-release tablets 8 mg, 12 mg and 16 mg).  

Actavis intends to begin shipping its product shortly and believes that, under applicable Hatch Waxman rules, it may be entitled to marketing exclusivity, the company stated.

Exalgo is indicated for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. For the 12 months ending Feb. 28, 2014, Exalgo had total U.S. sales of approximately $230 million, according to IMS Health data.