Perrigo Company plc has received final approval from the US Food and Drug Administration (FDA) for 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 labelling. Shipments to our 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.
Perrigo's chairman, president and CEO Joseph C. Papa stated, "This product approval and launch further strengthens our growing Rx portfolio and highlights our commitment to bringing affordable products to our customers."
Perrigo Company plc, a top five global over-the-counter (OTC) consumer goods and pharmaceutical company, offers consumers and customers high quality products at affordable prices.