Generic Exalgo Coming Soon from Perrigo
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.