The NDA is based on the results of a large, multicenter, open-label, randomized, Phase III trial that examined the repeated use of Amphora gel compared to a vaginal gel containing Nonoxynol-9 as the primary method of contraception over seven cycles of use.
Evofem chief executive officer Saundra Pelletier said: "Evofem is committed to our mission of empowering women by providing new innovations in women’s health and more ways for women to manage their fertility.
"Based on the results of the phase III trial, we believe Amphora can become an important and exciting new product for women and address a large unmet need in the market because it is woman-controlled, pericoital and hormone-free."
The company said that amphora, a non-hormonal vaginal gel, is applied discreetly before sexual intercourse.
Amphora, which is approved by the FDA as a lubricant, has been investigated as a contraceptive and is also being investigated for microbicidal properties to develop a potential multipurpose prevention technology.
The gel works by restoring the vaginal pH levels to those consistent with a healthy vaginal environment which is inhospitable towards both sperm and pathogens.
Evofem is focused on the discovery, development and commercialization of prescription and over-the-counter (OTC) products in the areas of feminine care, contraception, and the prevention of sexually transmitted infections.