FDA Approves New Treatment for Certain Systemic Fungal Infections


The FDA has approved Mayne Pharma Group Limited’s New Drug Application for SUBA-itraconazole (Tolsura) 65mg capsules.

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

SUBA-itraconazole is indicated for the treatment of blastomycosis, pulmonary and extrapulmonary; histoplasmosis, including chronic cavitary pulmonary disease and disseminated, nonmeningeal 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, such as those with a history of cancer, transplants, HIV/AIDS, or chronic rheumatic disorders, and are often associated with high mortality rates or long-term health issues.

According to Mayne Pharma CEO Scott Richards, the newly approved product represents a major milestone for the company in the SUBA (SUper-BioAvailable) drug delivery platform.

“Reformulation of existing drugs plays an important role in improving patient compliance and clinical outcomes. We are proud to offer a new treatment option for patients with these life-threatening infections,” said Mayne Pharma CEO Scott Richards, in a prepared statement. “We believe physicians will appreciate having access to Tolsura, which has been shown in clinical studies to have increased bioavailability and significantly reduced variability when compared to conventional oral itraconazole capsules."

Mayne Pharma’s SUBA-itraconazole capsules are expected to be made available in January 2019.


Mayne Pharma receives FDA approval of Tolsura™ (SUBA®-itraconazole capsules) for the treatment of certain fungal infections [news release]. Adelaide, Australia; December 11, 2018: Mayne Pharma. https://www.prnewswire.com/news-releases/mayne-pharma-receives-fda-approval-of-tolsura-suba-itraconazole-capsules-for-the-treatment-of-certain-fungal-infections-300763882.html. Accessed December 12, 2018.

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