Mallinckrodt receives FDA approval for Fentanyl Transdermal System patch ANDA

Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that Mallinckrodt Inc., a Covidien company, has received U.S. Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for its Fentanyl Transdermal System (FTS) patch. Covidien is the largest supplier of controlled pain medications in the United States based on number of prescriptions.

“Covidien continues to build on its extensive pain treatment experience by focusing on providing patients with a variety of medications to make pain more manageable”

Covidien's FTS is a generic alternative to the branded DURAGESIC^® patch. FTS, a Class II controlled substance, is an opioid analgesic indicated in opioid-tolerant patients for management of persistent, moderate to severe chronic pain that requires continuous, around-the-clock opioid administration for an extended period of time, and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids.

"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 our FTS product has been granted FDA approval, allowing us to introduce this treatment option for healthcare providers to better meet patients' needs."

Covidien expects to launch FTS in the U.S. in 25mcg/hr, 50mcg/hr, 75mcg/hr and 100mcg/hr strengths in the current quarter. The launch will be accompanied by an extensive risk management plan to help ensure the appropriate and safe use of this medication in accordance with both FDA guidance and Covidien's strong focus on patient safety. This plan is designed to minimize abuse and overdose, and includes patient and physician education material, a medication guide, and other tools to ensure patients who receive FTS understand the risks, appropriate use, storage, application and disposal of FTS.

"Covidien continues to build on its extensive pain treatment experience by focusing on providing patients with a variety of medications to make pain more manageable," said Matthew Harbaugh, Chief Financial Officer and Interim President, Pharmaceuticals, Covidien.

SOURCE Covidien