FDA approves Tolsura for fungal infections.- Mayne Pharma.

Mayne Pharma Group announced that the FDA has approved the New Drug Application (NDA) for Tolsura (SUBA-itraconazole) 65mg capsules. Tolsura is a new formulation of itraconazole indicated for the treatment of certain systemic fungal infections in adult patients.

Tolsura is indicated for the treatment of 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.