Perrigo launches Exalgo AB rated equivalent

US drugmaker Perrigo (NYSE: PRGO) says it has received final approval from the US Food and Drug Administration of its Abbreviated New Drug Application for hydromorphone HCI extended-release tablets 8mg, 12mg and 16mg.

The FDA concluded that Perrigo's products are therapeutically equivalent to Mallinckrodt’s (NYSE:MNK) Exalgo 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 Perrigo’s pharmacy customers will commence within the next few weeks, the company said.

Exalgo 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 about $133 million in 2014. Mallinckrodt’s sales of Exalgo fell 66.6% to $12.1 million in 2014.