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).

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Hydromorphone HCl Extended-Release Tablets will be available in 8mg, 12mg, and 16mg strengths. Perrigo intends to commence shipments within the next few weeks.

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