Mallinckrodt's (MNK) Prior Approval Supplement for OFIRMEV Receives FDA Approval

November 8, 2016 7:37 AM EST

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Mallinckrodt Pharmaceuticals (NYSE: MNK) announced the U.S. Food and Drug Administration (FDA) has approved a Prior Approval Supplement for OFIRMEV (acetaminophen) injection available in an intravenous (IV) bag presentation, which will provide health care providers an additional delivery option.

The Prior Approval Supplement to the approved OFIRMEV New Drug Application included the addition of a new container closure and manufacturer. The polypropylene bags will be manufactured by Fresenius Kabi. Mallinckrodt anticipates product availability in the second quarter of 2017.



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