The US Food and Drug Administration (FDA) has granted final approval to Actavis' Abbreviated New Drug Application (ANDA) for a generic version of Mallinckrodt Inc.'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.
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 February 28, 2014, Exalgo had total US sales of approximately $230 million, according to IMS Health data.
Actavis plc is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products.