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Australia based Mayne Pharma Group Limited is pleased to announce the launch of butalbital acetaminophen and caffeine (BAC) capsule 50mg/300mg/40mg in the United States. Mayne Pharma received approval from the US Food and Drug Administration for its Abbreviated New Drug Application, which is indicated for the treatment of tension headache (migraine).
Mayne Pharma's CEO Scott Richards said, "This launch complements our existing butalbital product range that includes a variety of dosage forms, strengths and combinations. Mayne Pharma continues to expand its product portfolio through internal product development, strategic alliances with best-in-class pharmaceutical developers and manufacturers and other business development activities."
According to IQVIA, US sales of BAC capsule 50mg/300mg/40mg were approximately US$40 million for the 12 months ending 31 March 2020. Mayne Pharma directly markets more than 60 generic and specialty branded pharmaceuticals in the United States.