Posted by Michael Wonder on 04 Jul 2017
Amphora (L-lactic acid, citric acid, and potassium bitartrate) receives QIDP designation from the FDA
29 June 2017 - Designation includes two separate indications and provides eligibility for priority review and additional exclusivity.
Evofem Biosciences, a biotechnology company focused on the development and commercialisation of women’s health products, today announced that its drug candidate, Amphora, being studied for contraception and treating sexually transmitted infections has been designated as a "Qualified Infectious Disease Product" (QIDP) by the U.S. FDA for two separate indications: the prevention of urogenital gonorrhoea infection in women, and to reduce the recurrent episodes of bacterial vaginosis.
“The studies we have conducted to date regarding contraception and vaginal infections suggest that Amphora may meet several unmet medical needs in women’s health,” said Saundra Pelletier, Evofem Biosciences CEO. “These two QIDP designations for Amphora are a significant advancement in our efforts to make this drug available to women at risk of infection."
