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.
Zhimeng Biopharma's investigational drug gains Phase 2 epilepsy clinical trial approval in China
Sanofi's SAR402663 granted FDA fast track designation for wet AMD
Implantica produces 10,000 RefluxStop units ahead of planned US launch
Sobi's Biologics License Application for NASP in uncontrolled gout accepted by FDA
Ionis receives FDA Breakthrough Therapy designation for ION582 in Angelman syndrome
Saol Therapeutics receives US FDA Complete Response Letter for SL1009 (DCA) in PDCD
Amneal's risperidone extended-release injectable suspension approved by US FDA
Brain+ pilot shows Ayla therapy boosts cognitive outcomes in dementia care
Ascelia Pharma files NDA with FDA for liver imaging drug Orviglance
Biophytis secures EMA clearance to advance Phase 2 obesity trial
Valneva reports strong Phase 2 booster results for Lyme disease vaccine candidate VLA15