Perrigo announced that it has received final approval from the Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Hydromorphone HCI Extended-Release Tablets, the generic version of Mallinckrodt‘s Exalgo.
Exalgo is an opioid indicated for the management of pain severe enough to require daily, around-the-clock, long-term analgesia for which alternative opioid therapies are inadequate. 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).
Hydromorphone HCl Extended-Release Tablets will be available in 8mg, 12mg, and 16mg strengths. Perrigo intends to commence shipments within the next few weeks.
For more information call (866) 634-9120 or visit Perrigo.com.