Actavis announced the FDA has granted final approval of its Abbreviated New Drug Application (ANDA) for Hydromorphone HCl Extended-Release Tablets, the generic version of Mallinckrodt’s Exalgo.

Exalgo is an opioid indicated for moderate to severe pain in opioid-tolerant patients when continuous opioid analgesia is needed for an extended time period. Hydromorphone is principally an agonist of mu-receptors, showing a weak affinity for kappa-receptors. The precise mechanism of action of opioid analgesics is not known but the effects are thought to be mediated through opioid-specific receptors located predominantly in the central nervous system (CNS).

RELATED: Narcotic Analgesics

Hydromorphone HCl Extended-Release Tablets will be available in 8mg, 12mg, and 16mg strengths. Actavis intends to commence shipment shortly.

For more information call (800) 432-8534 or visit