Table of Contents
ST. LOUIS — Covidien’s Mallinckrodt Inc. subsidiary has received approval from the Food and Drug Administration for its fentanyl transdermal system (FTS) patch.
Covidien said Thursday it expects to launch the FTS — a generic alternative to Ortho-McNeil’s Duragesic patch — in the United States this quarter in 25mcg/hr, 50mcg/hr, 75mcg/hr and 100mcg/hr strengths.
"Pain is one of the most common reasons patients consult a physician, yet it is often inadequately treated," stated Herbert Neuman, chief medical officer for pharmaceuticals at 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."
According to Covidien, the launch will be accompanied by an extensive risk management plan to help ensure the appropriate and safe use of the medication. The company said the plan is designed to minimize abuse and overdose and includes patient and physician education material, a medication guide and other tools to ensure patients understand the risks, proper use, storage, application and disposal of the 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," commented Matthew Harbaugh, chief financial officer and interim president of pharmaceuticals at Covidien.
Covidien’s 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 nonsteroidal analgesics, opioid combination products or immediate-release opioids.
