Perrigo Announces FDA Approval, Launch Of AB Therapeutic Equivalent To Exalgo

(RTTNews) - Perrigo Company plc (PRGO) said that it has received final approval from the U.S. Food and Drug Administration or FDA of its Abbreviated New Drug Application for hydromorphone HCI extended-release tablets 8 mg, 12 mg and 16 mg.

The FDA concluded that Perrigo's products are therapeutically equivalent to Mallinckrodt Inc.'s Exalgo 8 mg, 12 mg and 16 mg and can be substituted with the full expectation that it will produce the same clinical effect and safety profile when used under the conditions specified in the labeling. Shipments to pharmacy customers will commence within the next few weeks.

Exalgo (hydromorphone HCI extended-release tablets) is indicated for the treatment of chronic pain in opioid-tolerant patients requiring continuous around-the-clock opioid analgesia for an extended amount of time. Combined brand and generic sales were approximately $133 million in 2014.