(RTTNews) - SCYNEXIS, Inc. (SCYX) announced the FDA has accepted the company's submission of a supplemental New Drug Application to expand the label of BREXAFEMME to include the prevention of recurrent vulvovaginal candidiasis. The Submission has been granted priority review and given a target regulatory decision date of November 30, 2022.
SCYNEXIS said the regulatory submission for the label extension is supported by positive data from the phase 3 CANDLE study. The company will present CANDLE study results in the current week at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meeting.
BREXAFEMME is an oral antifungal approved for the treatment of vulvovaginal candidiasis, also known as vaginal yeast infection.
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