The Food and Drug Administration (FDA) has approved labeling changes for Ofirmev (acetaminophen; Mallinckrodt) injection to include recommended dosing for treatment of fever in neonates and infants.

Ofirmev, an analgesic/antipyretic, is already indicated for the management of mild to moderate pain or moderate to severe pain with adjunctive opioid analgesics, and fever, in patients aged ≥2 years. The updated labeling now includes dosage recommendations for neonates (including premature neonates born ≥32 weeks gestational age) up to 28 days chronological age, and for infants aged 29 days to 2 years. 

Related Articles

Ofirmev is currently available as 1000mg strength single-use vials in 24-count cartons. In November 2016, the FDA approved a new presentation for Ofirmev to be supplied in new intravenous (IV) bags. The IV bags are anticipated to launch in the second quarter of 2017.

For more information call (800) 778-7898 or visit