FDA approves Liletta for contraception-Actavis/Medicines360
Actavis and Medicines360 have announced the approval of Liletta (levonorgestrel-releasing intrauterine system) by the FDA 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, ACCESS IUS, conducted in the US 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 percent. Liletta is indicated for women regardless of parity or bmi. Actavis and Medicines360 expect that Liletta will be available for use in the US by q2 2015.
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