Mallinckrodt announced that the Food and Drug Administration (FDA) has approved a Prior Approval Supplement for Ofirmev (acetaminophen) injection available as an intravenous (IV) bag presentation. 

Prior to this, Ofirmev was available as 1000mg single-use vials in 24-count cartons. The Supplement proposed the addition of a new container closure and manufacturer, providing healthcare professionals with another drug delivery option. The approved propylene bags will be manufactured by Fresenius Kabi. 

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Ofirmev injection was approved in November 2010 for the management of mild to moderate pain, management of moderate to severe pain with adjunctive opioids, and for the reduction of fever

Ofirmev supplied in the new IV bags is anticipated to launch in the second quarter of 2017. Ofirmev is available to hospitals and outpatient and ambulatory surgical centers.

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