FDA Approves New Ofirmev Presentation

February 17, 2017 by Dr. Clemens Leave a Comment

The FDA has approved an IV bag presentation of acetaminophen (Ofirmev) injection, giving health care providers another delivery option, Mallinckrodt Pharmaceuticals announced.

Acetaminophen injection is the first—and currently the only—FDA-approved IV formulation of the drug in the United States, according to Mallinckrodt. It is indicated for the management of mild to moderate pain, management of moderate pain with adjunctive opioid analgesics and reduction of fever.

The FDA approved acetaminophen injection in November 2010 after reviewing data from multiple clinical trials evaluating the drug’s safety and efficacy for reducing pain and fever. One study, which included 101 orthopedic patients undergoing hip or knee replacement surgery, showed that 1,000 mg of acetaminophen injection every six hours was statistically superior to placebo for reducing pain intensity and morphine consumption over 24 hours (Pain Pract 2012;12:357-365).

This latest Prior Approval Supplement includes the addition of a new container closure and manufacturer. Mallinckrodt anticipated the new product to be available in the second quarter of 2017.

Based on a press release from Mallinckrodt.

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