Posted by Michael Wonder on 09 Aug 2021
Daré Bioscience announces FDA acceptance and priority review of new drug application for DARE-BV1 for the treatment of bacterial vaginosis
9 August 2021 - New drug application supported by positive data from the DARE-BVFREE Phase 3 study, which demonstrated clinical cure rates of 70-81% from a single vaginal dose of DARE-BV1.
Daré Bioscience today announced that the U.S. FDA accepted for filing the company’s new drug application for DARE-BV1 for the treatment of bacterial vaginosis.
The FDA granted this application priority review and set a Prescription Drug User Fee Act date of 7 December 2021 for the target completion of its review of the new drug application.
