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# Evofem Biosciences Re-files NDA for Amphora
- URL: https://www.fdaweb.com/evofem-biosciences-re-files-nda-for-amphora/
- Published: 2019-11-27T12:00:00.000Z
- Updated: 2026-09-14T15:54:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145612

Evofem Biosciences has resubmitted its NDA for Amphora (L-lactic acid, citric acid and potassium bitartrate), a multipurpose vaginal pH regulator for preventing pregnancy. The submission 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 1,400 healthy women aged 18-35 years. The trial was designed with FDA input to address questions raised in a 4/2016 complete response letter. FDA told the company that the Class 2 resubmission will have a six-month review.

Amphora is designed to regulate vaginal pH within the normal range of 3.5 to 4.5, even in the presence of semen, which normally raises the vaginal pH to 7.0 – 8.0, the company says. “This maintains an acidic environment that is inhospitable to sperm, as well as certain viral and bacterial pathogens associated with sexually transmitted infections, but it is integral to the survival of healthy bacteria in the vagina,” it says.