Posted by Michael Wonder on 01 Aug 2022
Scynexis announces U.S. FDA acceptance and priority review of the supplemental new drug application for Brexafemme (ibrexafungerp) for prevention of recurrent vaginal yeast infections
1 August 2022 - Submission has been granted priority review and given a target regulatory decision date of 30 November 2022.
Scynexis today announced that the U.S. FDA has accepted the Company’s submission of a supplemental new drug application to expand the label of Brexafemme (ibrexafungerp tablets) to include the prevention of recurrent vulvovaginal candidiasis.
