Australian company, Mayne Pharma announced this week that their antifungal drug, TOLSURA™ (SUBA®-itraconazole) 65mg capsule, will be launched in the United States.


TOLSURA is a new formulation of itraconazole indicated for the treatment of systemic fungal infections including blastomycosis (pulmonary and extrapulmonary), histoplasmosis (including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis) and aspergillosis (pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy).

These serious infections most commonly occur in vulnerable or immunocompromised patients, for example, those with a history of cancer, transplants (solid organ or bone marrow), HIV/AIDS, or chronic rheumatic disorders, and are often associated with high mortality rates or long-term health issues.

The Company received US Food and Drug Administration (FDA) approval for TOLSURA in December 2018.

Mayne Pharma’s CEO, Mr. Scott Richards said: “We are very pleased to launch TOLSURA – a new formulation of itraconazole incorporating Mayne Pharma’s proprietary SUBA-technology to improve the bioavailability of poorly soluble drugs. TOLSURA provides a new treatment option for patients and physicians fighting these life-threatening fungal infections. This launch has enabled Mayne Pharma to establish a new institutional sales team focused on hospital based infectious disease specialists. We look forward to bringing further specialty product innovations to market over the coming years with our pipeline of products under development.”