FDA approves Covidien's Abbreviated New Drug Application for CII

Covidien , a leading global provider of healthcare products, today announced that its subsidiary, Mallinckrodt Inc., has received U.S. Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for Oral Transmucosal Fentanyl Citrate (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.

“Pain is one of the most common reasons patients consult a physician, yet it is often inadequately treated,” said Herbert Neuman, M.D., Chief Medical Officer, Pharmaceuticals, Covidien. “We are pleased to receive this FDA approval and to introduce this treatment option to meet patients’ needs.”

Covidien expects to launch Oral Transmucosal Fentanyl Citrate in the U.S. in early calendar 2010, in 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,200 mcg and 1,600 mcg strengths. The launch will be accompanied by an extensive risk management plan to help ensure the appropriate and safe use of this medication.

“Covidien continues to build on its extensive pain treatment experience by focusing on providing patients with access to advanced medications,” said Timothy R. Wright, President, Pharmaceuticals, Covidien.