FDA Approves Tolsura for the Treatment of Certain Systemic Fungal Infections

Mayne Pharma announced that the Food and Drug Administration (FDA) has approved Tolsura (SUBA-itraconazole) capsules 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).  

Tolsura is a new formulation of itraconazole, an azole antifungal, that utilizes the Company’s proprietary SUBA (SUper-BioAvailable) technology to improve the bioavailability of poorly soluble drugs. Itraconazole works by inhibiting the cytochrome P450-dependent synthesis of ergosterol, which is a vital component of the fungal cell membrane. 

“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,” stated Scott Richards, Mayne Pharma CEO. 

Tolsura is not interchangeable or substitutable with other itraconazole products. It will be available as 65mg capsules in January 2019. 

For more information call (844) 825-8500 or visit MaynePharma.com.