Mallinckrodt Pharmaceuticals announced that the US 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.
OFIRMEV (acetaminophen) 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
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical and biopharmaceutical products and therapies, as well as nuclear imaging products.
Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and hemostasis products; and central nervous system drugs.