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FDA Extends Use of Medicine360’s Contraceptive Device

November 18, 2022

The FDA has approved the extended use of Medicines360’s Liletta hormonal intrauterine system to prevent pregnancy for up to eight years.

Once implanted by a clinician, the reversible contraceptive system slowly releases the progestin hormone levonorgestrel into the uterus. Liletta was initially approved for three years of use in 2015. Subsequent clinical trial data led to the use being extended, the last time to six years in 2020.

The latest approval is based on data from a phase 3 trial in which Liletta was about 99 percent effective in preventing pregnancy up to eight years in a diverse population of 1,751 women. Eleven pregnancies occurred over eight years, seven of which were ectopic.

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