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FDA Approves New Pain Med Delivery Method

November 08, 2016

Leading global specialty pharmaceutical company Mallinckrodt Pharmaceuticals recently announced that the US Food and Drug Administration (FDA) has approved a Prior Approval Supplement for acetaminophen injection (Ofirmev®) available in an intravenous (IV) bag presentation, giving providers and additional delivery option.

Ofirmev Injection is indicated for the management of mild to moderate pain, management of moderate to severe pain with adjunctive opioid analgesics, and reduction of fever.
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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.

Ofirmev injection is the first and only IV formulation of acetaminophen to be approved and currently marketed in the United States and was FDA-approved in November 2010. It is available to hospitals and outpatient and ambulatory surgical centers across the United States.

—Amanda Del Signore


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