Supplemental NDA filed for Liletta (levonorgestrel-releasing intrauterine system) with FDA for long-term contraception- Allergan
Allergan has announced that the U.S. FDA has accepted for filing the company's supplemental New Drug Application (sNDA) to potentially extend the duration of use for the prevention of pregnancy from up to three years to up to four years for Liletta (levonorgestrel-releasing intrauterine system) 52 mg.
The supplement currently being reviewed by FDA includes additional efficacy and safety data from an ongoing U.S.-based Phase III hormonal IUD trial, ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS), with 1,751 women receiving Liletta. Liletta was shown to be safe and effective for a broad range of women regardless of age, race, parity or Body Mass Index.
Comment: Liletta was first approved in February 2015 with a two-handed inserter and received additional FDA approval in January 2016 for a new single-handed inserter.
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