Complete Response Letters
Evofem, Inc.: Amphora
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Apr 28, 2016
Act for Amphora (lactic acid 1.76 %, citric acid 1%, and potassium bitartrate 0.4%) vaginal gel.
CRL_NDA208352_20160428:p1:s15Based on the results in the US population in this efficacy analysis, you have not provided sufficient evidence of efficacy for Amphora gel for the prevention of pregnancy, as this analysis failed to meet your prespecified non-inferiority criterion.
CRL_NDA208352_20160428:p1:s24Further, your sensitivity analysis of efficacy according to "dosing deviations" did not address our request for efficacy data stratified by the interval between gel application and intercourse.
CRL_NDA208352_20160428:p1:s32The statistical analysis plan should be pre-specified and submitted for review and comment prior to locking the database.
CRL_NDA208352_20160428:p2:s2More Complete Response Letters
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