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Pharmaceuticals / Regulatory Affairs / Submissions and Approvals

FDA Extends Review of Mallinckrodt’s Xartemis NDA

Nov. 26, 2013

The FDA has extended its review of Mallinckrodt’s NDA for its investigational painkiller Xartemis XR by 90 days, saying it needs more time to review the drug’s proposed labeling.

Xartemis, a combination of oxydocone hydrochloride and acetaminophen, is designed to treat moderate to severe acute pain in patients who can handle treatment with an opioid analgesic.

The agency accepted the drugmaker’s NDA filing in July and granted it priority review. Mallinckrodt has since submitted supplemental information related to Xartemis XR’s formulation in the course of ongoing labeling discussions, spokesperson Lynn Phillips said.

Mallinckrodt remains confident that Xartemis, which has not been approved outside the U.S., will be cleared by the FDA and hit store shelves by the first half of 2014. — Lena Freund

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