FDA approves Perrigo’s Exalgo extended-release generic

SILVER SPRING, Md. — Perrigo is adding to its portfolio of opioid generics. The Food and Drug Administration has approved the company’s generic of Exalgo (hydromorphone HCL, 32 mg) extended-release tablets.

The drug is an opioid indicated to manage moderate to severe pain in patients requiring continuous around-the-clock pain opioid analgesia for an extended period of time. Perrigo said it planned to make the generic available by the end of September.

The drug had brand and generic sales of $35 million for the 12 months ended July 2017, the company said.