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Mayne Pharma Group Announces FDA's Approval of Tolsura (SUBA-itraconazole) Capsules

12 Dec 2018  |  09:01:00  |  Associate analysts  |  Increase  |  Decrease  |  

Original announcement: FDA approval of Tolsura (SUBA-itraconazole) capsules

Mayne Pharma Group announced that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Tolsura (SUBA-itraconazole) 65mg capsules. Tolsura is a formulation of itraconazole indicated for the treatment of certain systemic fungal infections in adult patients. The Company will directly commercialise Tolsura and plans to launch in January 2019 with an institutional sales team focused on hospital-based infectious disease specialists. Tolsura has four granted patents from the US Patent and Trademark Office with expiry dates ranging from 2023 to 2033. The US anti-fungal triazole market has a current value of US$600m according to IQVIA and based on the clear unmet clinical need in serious systemic infections, the addressable market is estimated at US$200m.

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