US regulator gives nod to Mayne Pharma's new anti-fungal product

12 December 2018

The US regulator has granted approval to Adelaide-based Mayne Pharma (ASX: MYX) for its Tolsura (itraconazole) product, a new formulation of itraconazole indicated for the treatment of certain systemic fungal infections in adults.

The approval covers certain serious infections most commonly occur in vulnerable or immunocompromized patients, for example, those with a history of cancer, transplants, HIV/AIDS, or chronic rheumatic disorders.

The product incorporates Mayne’s proprietary SUBA technology to improve the bioavailability of poorly soluble drugs.

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