Evofem Biosciences, Inc., a medical-stage biopharmaceutical firm, at the moment, introduced that it has resubmitted it is New Drug Software (NDA) to the U.S. Meals and Drug Administration (FDA) for Amphora, a Multipurpose Vaginal pH Regulator (MVP-R), for the prevention of being pregnant.
“Immediately’s submission represents a major step ahead for Evofem and for the hundreds of thousands of girls who’re dissatisfied with their present contraceptive choices and are eagerly awaiting a brand new different,” mentioned Saundra Pelletier, Evofem Biosciences’ Chief Govt Officer.
“We have now submitted a complete and compelling package deal that we consider addresses the Company’s excellent questions, and we look ahead to the potential alternative to supply hundreds of ladies with a revolutionary new hormone-free, on-demand, a prescription contraceptive choice that offers them management over their sexual and reproductive health.”
The Amphora NDA resubmission consists of full outcomes from Section three EMPOWER research, a confirmatory one-arm, open-label Part three trial evaluating the security and efficacy of Amphora in roughly 1,400 wholesome ladies aged 18-35 years. The test was designed with steerage and enter from the FDA to deal with questions raised within the Full Response Letter obtained by Evofem in April 2016.
In keeping with the FDA’s classification, this utility will probably have thought of as a Class 2 resubmission. Under the Prescription Drug Person Price Act (PDUFA), FDA assessment of a Class two resubmission is anticipated to be accomplished inside a six-month interval starting on the date the resubmission is acquired.