Mallinckrodt gains FDA approval for Xartemis XR

12 March 2014

The US Food and Drug Administration has approved Ireland-headquartered specially drugmaker Mallinckrodt’s (NYSE: MNK) Xartemis XR (oxycodone hydrochloride and acetaminophen) extended-release tablets (previously known as MNK-795).

The approval is for the management of acute pain severe enough to require opioid treatment and in patients for whom alternative treatment options (eg, non-opioid analgesics) are ineffective, not tolerated or would otherwise be inadequate. Xartemis XR is the first and only extended-release oral combination of two clinically proven pain medications -- oxycodone and acetaminophen, the company noted.

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