announced that the 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 ...
Infections occurred following variable duration-of-use. One participant diagnosed with PID and two participants diagnosed with endometritis developed the infection within a week of LILETTA insertion. One case of endometritis was diagnosed at 39 days after LILETTA insertion. The remaining 11 cases of...
LILETTA may come out of your uterus (expulsion). Expulsion occurs in about 4 out of 100 women, most often in the first year of use. You may become pregnant if LILETTA comes out. If you think that LILETTA has come out, use another birth control method like condoms and spermicide or ...
Objective: To understand the potential duration of action for Liletta, we conducted this study to estimate levonorgestrel release rates over approximately 5years of product use. Methods: Clinical sites in the U.S. phase 3 study of Liletta collected the levonorgestrel (LNG) intrauterine systems (...
Objective: To understand the potential duration of action for Liletta (R), we conducted this study to estimate levonorgestrel (LNG) release rates over approximately 51/2 years of product use.Creinin, Mitchell D.Jansen, RolfStarr, Robert M.Gobburu, JogaGopalakrishnan, MathangiOlariu, Andrea...