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news.Perrigo has received final US Food and Drug Administration (FDA) approval for the generic version of Mallinckrodt Pharmaceuticals' Ofirmev (acetaminophen) injection 1000 mg/100 mL.
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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.
Perrigo’s CEO John T. Hendrickson stated, "This product approval demonstrates the strength of Perrigo’s Rx portfolio. Approvals in difficult formulations like this are what drive Perrigo’s diverse product portfolio, which continues to provide a unique offering to our customers around the world."