Policy & Regulation
Evofem Biosciences resubmits Amphora New Drug Application to US FDA
29 November 2019 -

Evofem Biosciences Inc, a clinical-stage biopharmaceutical company, has resubmitted its New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for Amphora, a Multipurpose Vaginal pH Regulator (MVP-R), intended for the prevention of pregnancy, it was reported yesterday.

The Amphora NDA resubmission provides complete results from the Phase three AMPOWER study, a confirmatory single-arm, open-label Phase three trial assessing the safety and efficacy of Amphora in around 1,400 healthy women aged 18-35 years. The trial was designed with guidance and input from the US FDA to address questions raised in the Complete Response Letter received by the company in April 2016.

Saundra Pelletier, Evofem Biosciences' chief executive officer, said, 'Today's submission represents a significant step forward for Evofem and for the millions of women who are dissatisfied with their current contraceptive options and are eagerly awaiting a new alternative. We have submitted a comprehensive and compelling package that we believe addresses the Agency's outstanding questions, and we look forward to the potential opportunity to provide millions of women with an innovative new hormone-free, on-demand, prescription contraceptive option that gives them control over their sexual and reproductive health.'

According to the FDA's classification, this application will be considered a Class 2 resubmission. Under the Prescription Drug User Fee Act (PDUFA), FDA review of a Class 2 resubmission is expected to be completed within a six-month period beginning on the date the resubmission is received.



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