U.S. Food and Drug Administration (FDA) Extends Review of Mallinckrodt’s New Drug Application for XARTEMIS XR (oxycodone hydrochloride and acetaminop

29-11-2013 Business Wire HealthComments (0)


Mallinckrodt (NYSE: MNK) today announced that the U.S. Food and Drug Administration (FDA) extended the review of the New Drug Application (NDA) for investigational compound XARTEMIS™ XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII). XARTEMIS XR, previously known as MNK-795, was studied for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. The three-month extension from the FDA is in respo

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