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news.The Food and Drug Administration (FDA) has granted final approval for Irish OTC firm Perrigo's abbreviated new drug application (ANDA) for hydromorphone HCI extended-release tablets 8 mg, 12 mg and 16 mg.
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The FDA concluded that Perrigo’s products are therapeutically equivalent to Mallinckrodt’s Exalgo (hydromorphone HCI extended-release tablets) 8mg, 12mg and 16mg.
According to the agency these products 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.
The company said that shipments to its pharmacy customers will be initiated within the next few weeks.
Exalgo is indicated to treat chronic pain in opioid-tolerant patients requiring continuous around-the-clock opioid analgesia for an extended amount of time.
Perrigo chairman, president and CEO Joseph Papa said: "This product approval and launch further strengthens our growing Rx portfolio and highlights our commitment to bringing affordable products to our customers."
The company also produces branded OTC products, generic extended topical prescription products and receives royalties from multiple sclerosis drug Tysabri.