Medicines360, a global nonprofit organization with a mission to expand women’s access to quality medicines, announced today that the U.S. Food and Drug Administration (FDA) has approved Medicines360’s Supplemental New Drug Application (sNDA) to extend the duration of use of Liletta® (levonorgestrel-releasing intrauterine system) 52 mg to prevent pregnancy for up to eight years. This approval is based on data from ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS) that Medicines360 first published in the American Journal of Obstetrics and Gynecology in May 2022. With this FDA approval, Liletta has one of the longest approved durations of use for a hormonal intrauterine device (IUD or IUS) in the U.S. Originally approved by the FDA on February 26, 2015, Liletta (levonorgestrel) is a hormonal intrauterine device (IUD) for use by women to prevent pregnancy for up to eight years.
