Covidien Gets FDA Approval for Generic Version of Actiq Fentanyl Lozenge

By Jim Greene

Published on December 17, 2009

Covidien PLC has announced its intention to market a generic version of the Actiq® fentanyl citrate painkiller lozenge by early 2010, after recent approval by the Food and Drug Administration (FDA). It will be produced by Covidien subsidiary Mallinckrodt, Inc.

Covidien, already the country's largest producer of controlled substances for pain relief, will join Teva Pharmaceuticals subsidiary Barr Pharmaceuticals in the production of a generic fentanyl lozenge. The Actiq® branded version is a product of Cephalon, Inc.

Fentanyl is a powerful, addictive opioid painkiller prescribed primarily for cancer patients who have become resistant to other opioids. The lozenge form is known as an oral transmucosal; it is on the end of a stick and is used like a lollipop. The lozenge will be produced in dosages of 200, 400, 600, 800, 1200, and 1600 micrograms.

Because fentanyl is highly addictive and has been linked to cases of serious injury and death due to overdose, Covidien will introduce an extensive risk management plan with the release of the lozenges. The company said they are intended only for use by patients 16 years of age and older who have malignancies.

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