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Perrigo to release Exalgo generic

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DUBLIN, Ireland — Perrigo Co. plc has received approval from the Food and Drug Administration for hydromorphone HCl extended-release tablets 32 mg, an opioid pain medication.

Perrigo said it expects to launch its hydromorphone product, a generic verison of Exalgo 32-mg ER tablets from Mallinckrodt, by the end of this month.

An opioid agonist, Exalgo is indicated for the management of moderate to severe pain in opioid-tolerant patients requiring continuous, around-the-clock treatment for an extended time period.

U.S. sales for the branded and generic equivalents of Exalgo 32-mg ER tablets totaled approximately $35 million for the 12 months through the end of July, according to IMS Health data reported by Perrigo.

“This final approval exemplifies Perrigo’s commitment to developing quality, high-value alternatives in important treatment categories,” stated John Wesolowski, executive vice president and president of Rx Pharmaceuticals at Perrigo. “The Rx team continues to leverage our development capabilities to deliver quality affordable health care products to customers, consumers and families around the world.”


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