Posted by Michael Wonder on 17 Oct 2018
FDA approves Medicines360’s sNDA for Liletta (levonorgestrel-releasing intrauterine system) 52 mg to prevent pregnancy for up to five years
16 October 2018 - Allergan and Medicines360 announced that the U.S. FDA approved Medicines360’s supplemental new drug application to extend the duration of use of Liletta (levonorgestrel-releasing intrauterine system) 52 mg for the prevention of pregnancy for up to five years.
The FDA approval was based on a review of additional efficacy and safety data from the largest ongoing intrauterine system (IUS), otherwise known as intrauterine device, Phase 3 clinical trial in the U.S., ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS), with 1,751 U.S. women receiving Liletta.
Liletta proved to be more than 99% effective in preventing pregnancy for up to 5 years in a broad range of women. Liletta is effective regardless of age, race, body mass index or parity (whether or not the woman had given birth to at least one child).
