New fungal medication for the U.S. market

February 5, 2019

The Food and Drug Administration(FDA) approved in December a new drug application for Tolsura (SUBA-itraconazole), a new formulation of itraconazole for the treatment of systemic fungal infections in adults.

The Food and Drug Administration (FDA) approved in December a new drug application for Tolsura (SUBA-itraconazole), a new formulation of itraconazole for the treatment of systemic fungal infections in adults.

Tolsura, which will be sold as 65 mg capsules, 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 infections occur in vulnerable or immunocompromised patients, such as patients with a history of cancer, transplants (solid organ or bone marrow), HIV/AIDS, or chronic rheumatic disorders. They are often associated with high mortality rates or long-term health issues, according to Mayne Pharma Group Limited, which issued a statement about the approval.

Mayne Pharma expects to launch the product in the U.S. by the end of first quarter 2019. It is one of more than 60 products the company markets in the United States, including Fabior (tazarotene) foam, Sorilux (calcipotriene) foam and Doryx MPC (doxycycline) delayed-release tablets. They recently acquired Lexette (halobetasol) foam for plaque psoriasis which is also expected to be launched by end of the first quarter 2019.

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