FDA Approves Medicines360's LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Eight Years
SAN FRANCISCO, Nov. 14, 2022 /PRNewswire/ -- 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.
- LILETTA was approximately 99% effective in preventing pregnancy for up to eight years in a diverse population of women.
- LILETTA is a hormone-releasing system placed in the uterus to prevent pregnancy for up to eight years.
- LILETTA (levonorgestrel-releasing intrauterine system) 52mg is a hormone-releasing system placed in your uterus to prevent pregnancy for as long as you want for up to 8 years.
- If you get pregnant while using LILETTA, you may have an ectopic pregnancy, which means the pregnancy is not in the uterus.