Posted by Michael Wonder on 18 Dec 2019
U.S. FDA acknowledges receipt of Evofem Biosciences' new drug application resubmission for Amphora for the prevention of pregnancy
18 December 2019 - Assigns PDUFA goal date of 25 May 2020.
Evofem Biosciences today announced that the U.S. FDA acknowledged receipt of the new drug application resubmission for Amphora, a Multipurpose Vaginal pH Regulator (MVP-R), for the prevention of pregnancy. Deemed a Class 2 resubmission by the FDA, the agency has assigned a six-month review period and a Prescription Drug User Fee Act goal date of 25 May 2020.
The Amphora resubmission includes full results from the Phase 3 AMPOWER study, a confirmatory single-arm, open-label Phase 3 trial that evaluated the efficacy and safety of Amphora in approximately 1,400 healthy women ages 18 to 35 years.
