Pharmacy News Article

Nov 03, 2009 (Datamonitor via COMTEX) Covidien, a provider of healthcare products, has reported that its subsidiary, Mallinckrodt has received the FDA's approval of its abbreviated new drug application for oral transmucosal fentanyl citrate, or CII.

Covidien's product is a generic alternative to the branded Actiq. It is a solid formulation of fentanyl that resembles a lozenge on a handle.

Oral transmucosal fentanyl citrate, a class II controlled substance, is an opioid analgesic indicated only for the management of breakthrough cancer pain in patients 16 years of age and older with malignancies who are already receiving and who are tolerant to opioid therapy for their underlying, persistent cancer pain, Covidien said.

Covidien expects to launch oral transmucosal fentanyl citrate in the US in early calendar 2010, in 200mcg, 400mcg, 600mcg, 800mcg, 1,200mcg and 1,600mcg strengths. The launch will reportedly be accompanied by an extensive risk management plan to help ensure the appropriate and safe use of this medication.

Herbert Neuman, chief medical officer of pharmaceuticals at Covidien, said: "Pain is one of the most common reasons patients consult a physician, yet it is often inadequately treated. We are pleased to receive this FDA approval and to introduce this treatment option to meet patients' needs."

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