Perrigo Says FDA Oks Generic Version Of Ofirmev Acetaminophen Injection

(RTTNews) - Perrigo Company plc (PRGO) announced it has received final U.S. Food and Drug Administration approval for the generic version of Mallinckrodt Pharmaceuticals' Ofirmev (acetaminophen) injection 1000 mg/100 mL.

As previously announced, Perrigo can launch a generic version of Ofirmev (acetaminophen) injection on December 6, 2020, or earlier under certain circumstances. In addition, Perrigo has secured the right to be the sole authorized generic distributor should Mallinckrodt elect to launch an authorized generic product.

Ofirmev (acetaminophen) injection 1000 mg/100 mL is indicated for the management of mild to moderate pain, management of moderate to severe pain with adjunctive opioid analgesics, and reduction of fever. Branded sales for the twelve months ending April 2016 were $275 million.