Posted by Michael Wonder on 27 Nov 2019
Evofem Biosciences resubmits new drug application to U.S. FDA for Amphora for the prevention of pregnancy
26 November 2019 - FDA decision anticipated within six months.
Evofem Biosciences today announced that it has resubmitted its new drug application to the U.S. FDA for Amphora, a multipurpose vaginal pH regulator (MVP-R), for the prevention of pregnancy.
The Amphora resubmission includes full results from the Phase 3 AMPOWER study, a confirmatory single-arm, open-label Phase 3 trial evaluating the safety and efficacy of Amphora in approximately 1,400 healthy women aged 18-35 years. The trial was designed with guidance and input from the FDA to address questions raised in the complete response letter received by Evofem in April 2016.
