US FDA’s Botanical Drugs Guidance Will See Rare Outing For Amryt’s Filsuvez NDA

Amryt’s birch bark extract oleogel-S10 for Epidermolysis Bullosa patients might become only the third botanical drug to clear the FDA.

FILSUVEZ CONTAINS DRY EXTRACT OF BARK FROM BIRCH TREES (BETULAE CORTEX), A NATURAL SUBSTANCE THAT PROVIDES BETULIN AND RELATED TRITERPENE COMPOUNDS • Source: Alamy

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