Filing Imminent As Mycovia’s Antifungal Prevents Recurrent Vulvovaginal Candidiasis
Private Company Is Preparing For Commercialization, Talking To Partners
Oteseconazole prevented recurrent VVC in two Phase III studies but Phase III data in acute treatment of VVC episodes in women with RVVC, also due this month, are needed to file for US FDA approval in the first half of 2021.
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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Biotech plans to file its first-in-class triterpenoid agent for approval in 2020 following a second Phase III study in acute vulvovaginal candidiasis. Beyond that, it hopes for a supplemental approval in recurrent VVC.