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Covidien Fentanyl Transdermal System patch obtains FDA approval

Covidien, a global provider of healthcare products, reported that Mallinckrodt, a Covidien company, has received US Food and Drug Administration (FDA) approval for its abbreviated new drug application (ANDA) for its Fentanyl Transdermal System (FTS) patch.

Covidien’s FTS patch is a generic alternative to the branded DURAGESIC patch of Johnson and Johnson.

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.

Covidien expects to launch FTS in the US in 25mcg/hr, 50mcg/hr, 75mcg/hr and 100mcg/hr strengths in the current quarter.

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 who receive FTS understand the risks, appropriate use, storage, application and disposal of FTS.