FDA Approves Liletta

Last month, the FDA approved a new safe, effective, long-term option for contraception. Liletta (levonorgestrel-releasing intrauterine system) was approved for use by women to prevent pregnancy for up to three years. Liletta is placed in the uterus by a healthcare professional and works by continuously releasing levonorgestrel (a progestin) to prevent pregnancy.

The approval of LILETTA was based on the largest hormonal IUD trial conducted in the U.S. with over 1,700 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 percent. LILETTA is indicated for women regardless of parity or BMI.

Liletta is a small, flexible plastic T-shaped system that works to prevent pregnancy by slowly releasing levonorgestrel (LNG), a progestin, at an initial release rate of 18.6 mcg/day with an average in vivo release rate of LNG of approximately 15.6 mcg/day over a period of three years. Liletta can be inserted 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 Liletta, if continued contraceptive protection is desired by the patient.