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Perrigo set to ship generic version of Exalgo

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DUBLIN, Ireland — Perrigo Co. plc has received approval from the Food and Drug Administration for hydromorphone HCI extended-release tablets (8 mg, 12 mg and 16 mg), an opioid pain medication.

Perrigo said that it expects to begin shipments of the product to pharmacies within the next few weeks.

The FDA concluded that Perrigo’s products are therapeutically equivalent to Mallinckrodt Inc.’s Exalgo 8-mg, 12-mg and 16-mg tablets 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, according to Perrigo.

Hydromorphone HCI extended-release tablets are indicated for the treatment of chronic pain in opioid-tolerant patients requiring around-the-clock opioid analgesia for an extended period of time. Combined brand and generic sales of the drug were about $133 million in 2014, Perrigo reported.

“This product approval and launch further strengthens our growing Rx portfolio and highlights our commitment to bringing affordable products to our customers,” stated Perrigo chairman, president and chief executive officer Joseph Papa.


ECRM_06-01-22


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