Medicines company Mayne Pharma Group Limited (ASX:MYX) reported on Tuesday the receipt of the US Food and Drug Administration (FDA) approval for the New Drug Application (NDA) for the antifungal Tolsura (SUBA-itraconazole) in 65 mg capsules for the treatment of certain systemic fungal infections in adult patients.

Tolsura, a new formulation of itraconazole, is indicated for the treatment of fungal infections in blastomycosis (pulmonary and extrapulmonary), histoplasmosis (including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis) and aspergillosis (pulmonary and extrapulmonary). These serious infections occur in vulnerable or immunocompromised patients, including with history of cancer, transplants (solid organ or bone marrow), HIV/AIDS, or chronic rheumatic disorders.

In conjunction, the company's Tolsura has four granted patents from the US Patent and Trademark Office, with expiry dates ranging from 2023 to 2033, which incorporates its proprietary SUBA technology to improve the bioavailability of poorly soluble drugs.

Additionally, the company will directly commercialise Tolsura and plans to launch in January 2019 with a new institutional sales team focused primarily on hospital-based infectious disease specialists. The US anti-fungal triazole market has a current value of USD600m according to IQVIA .