Mayne Pharma Group (ASX:MYX) has received FDA approval for its Tolsura treatment.
The US Food and Drug Administration has approved Tolsura as a treatment of certain systemic fungal infections in adult patients.
Mayne Pharma will directly commercialize Tolsura and plans to launch in January 2019.
(The US anti-fungal triazole market has a current value of US$600 million.)
The company says after many years of research and development and working closely with key global opinion leaders in infectious disease management, Tolsura represents a major milestone in the Super-BioAvailable drug delivery platform at Mayne Pharma.
Shares in Mayne Pharma Group (ASX:MYX) are 2.8 per cent higher 92 cents