SCYX - FDA accepts Scynexis' application to expand label for vaginal yeast infections treatment
- Scynexis ( NASDAQ: SCYX ) on Monday said the U.S. Food and Drug Administration (FDA) had accepted the biotech's supplemental new drug application (sNDA) to expand the label of its Brexafemme tablets to include the prevention of recurrent vulvovaginal candidiasis.
- Vulvovaginal candidiasis (VVC) is a type of yeast infection caused by the fungus candida which affects the vagina and the vulva.
- The company said the FDA had granted the sNDA submission a priority review and was set to decide on it by Nov. 30, or the so-called Prescription Drug User Fee Act date.
- Brexafemme is already approved to treat VVC. Recurrent VVC would be its second indication.
For further details see:
FDA accepts Scynexis' application to expand label for vaginal yeast infections treatment