Pharmaceutical company Mayne Pharma Group Limited (ASX:MYX) said on Thursday that it has launched its butalbital acetaminophen and caffeine (BAC) capsule in 50mg/300mg/40mg in the United States for the treatment of tension headache (migraine).
It comes after the company received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application for BAC.
US sales of BAC capsule 50mg/300mg/40mg were approximately USD40m for the 12 months ending 31 March 2020, according to IQVIA.
Mayne Pharma markets more than 60 generic and specialty branded pharmaceuticals in the US.
Viatris names new chief legal officer
Alvotech signs biosimilar supply and commercialisation deals with Sandoz
InSysBio agrees new collaborative project with BeOne Medicines
MS Pharma enters strategic partnership with Hetero Group
Apiject to open new generic injectable drug manufacturing facility in Apex, NC
Bionpharma and STEERLife's Etravirine tablets approved by US FDA
ScinoPharm Taiwan secures first US FDA approval for complex multiple sclerosis generic
ScinoPharm Taiwan's Glatiramer Acetate Injection approved by US FDA
Accord Healthcare launches Clomiphene tablets in US market
Zentiva receives ESG Transparency Award 2025
Galmed Pharmaceuticals reports topline results for combination of Aramchol, Stivarga and metformin
Ingenus Pharmaceuticals' generic equivalent to Premarin receives US FDA approval
EirGenix signs second global exclusive licensing deal with Sandoz