Mallinckrodt pharma leading global specialty pharmaceutical company, 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
OFIRMEV (acetaminophen) injection is the first and only intravenous (IV) formulation of acetaminophen to be approved and currently marketed in the United States. The U.S. Food and Drug Administration approved OFIRMEV in November 2010. OFIRMEV is available to hospitals and outpatient and ambulatory surgical centers across the U.S.
Subscribe to PharmaTutor News Alerts by Email
