Posted by Michael Wonder on 22 Feb 2018
FDA acceptance of Medicines360's filing for supplemental new drug application for Liletta (levonorgestrel-releasing intrauterine system) 52 mg
22 February 2018 - Application seeks to extend duration of use up to 5 years for Liletta.
Allergan today announced that the U.S. FDA has accepted for filing Medicines360's supplemental new drug application. The application aims to extend the duration of use for the prevention of pregnancy from up to four years to up to five years for Liletta (levonorgestrel-releasing intrauterine system) 52 mg.
The application currently being reviewed by the FDA is based on additional efficacy and safety data from the largest ongoing Phase 3 hormonal IUD trial in the U.S., ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS [intrauterine system]), with 1,751 women receiving Liletta.
