Actavis and Medicines360 announced that the Food and Drug Administration (FDA) has approved Liletta (levonorgestrol-releasing intrauterine system) for use by women to prevent pregnancy for up to three years.
Liletta is a small, flexible plastic T-shaped system, which works to prevent pregnancy by slowly releasing levonorgestrel, a progestin. It can be inserted into the uterus at any time if the provider is reasonably certain that the woman is not pregnant. While Liletta is intended for use up to three years, it can be removed by a healthcare professional at any time. Liletta can be replaced at the time of removal with a new one, if continued contraceptive protection is desired.
The approval of Liletta was based on a hormonal IUD trial, ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS), with 1,751 enrolled women receiving Liletta. Liletta was safe and effective for a broad range of women, with a cumulative three year efficacy rate of 99.45%. Liletta is indicated for women regardless of parity or BMI.
Liletta will be available in the second quarter of 2015.