Evofem announced today that the Food and Drug Administration (FDA) has designated its drug candidate, Amphora (L-lactic Acid, citric acid, and potassium bitartrate), as a Qualified Infectious Disease Product (QIDP) for 2 separate indications: to prevent urogenital gonorrhea infection in women and to reduce episodes of bacterial vaginosis.
Amphora is being developed as a vaginal contraceptive gel, and for the prevention of certain vaginal infections. It is hormone-free and can be used with other forms of contraception or used alone. The gel, supplied in a pre-filled applicator, can be self-applied.
The QIDP designation qualifies a drug product for additional 5 years of marketing exclusivity and makes it eligible for the FDA’s fast-track program. Drug candidates that receive a QIDP designation also receive a priority review with the FDA acting on an NDA within 6 months.
For more information call (858) 550-1900 or visit Evofem.com