AUSTRALIAN-LISTED specialty pharmaceutical company Mayne Pharma has welcomed the US Food and Drug Administration (FDA) approval of a New Drug Application for Tolsura (SUBA-itraconazole) capsules 65mg.
Tolsura is a new formulation of the active ingredient indicated for the treatment of certain systemic fungal infections in adults.
The formulation incorporates Mayne's proprietary SUBA technology which improves the bioavailability of poorly soluble drugs and improves the consistency of effect compared to earlier forms of the product.
Mayne will commercialise Tolsura directly and launch next month.
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