Liletta (levonorgestrel-releasing intrauterine system) 52 mg IUD single-handed inserter for contraception launched in US- Allergan / Medicines360
Allergan announced the launch of the new Liletta (levonorgestrel-releasing intrauterine system) 52 mg IUD single-handed inserter (intrauterine device), for use by women to prevent pregnancy for up to three years. The launch and availability of the single-handed inserter follows the U.S. Food and Drug Administration (FDA) approval received in January 2016.
The approval of the new single-handed inserter was based on the largest hormonal IUD trial, ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS), conducted in the U.S. with 1,751 enrolled women receiving Liletta , the same trial that supported the initial approval of Liletta . Liletta was shown to be 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 Body Mass Index (BMI) and can be inserted on the same day she visits the clinic, providing that she is not pregnant. During the ACCESS IUS clinical trial, the success rate for insertions with the new single-handed inserter was 99.2%.
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