16.10.2018 15:12:49
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FDA Oks Medicines360' SNDA For LILETTA 52Mg To Prevent Pregnancy For Up To 5-yrs
(RTTNews) - Allergan plc (AGN) and Medicines360, a global nonprofit women's health pharmaceutical company with a mission of expanding access to quality medicines, said that the U.S. Food and Drug Administration approved Medicines360's Supplemental New Drug Application or sNDA to extend the duration of use of LILETTA or levonorgestrel-releasing intrauterine system 52 mg for the prevention of pregnancy for up to five years.
The FDA approval was based on a review of additional efficacy and safety data from the largest ongoing intrauterine system (IUS), otherwise known as intrauterine device (IUD), Phase 3 clinical trial in the U.S., ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS), with 1,751 U.S. women receiving LILETTA.
LILETTA proved to be more than 99 percent effective in preventing pregnancy for up to 5 years in a broad range of women. LILETTA is effective regardless of age, race, body mass index (BMI) or parity (whether or not the woman had given birth to at least one child).
Medicines360 noted that LILETTA is commercially available in the U.S., and through Medicines360's unique mission-driven model, LILETTA is available at a lower cost to public health clinics enrolled in the 340B Drug Pricing Program.
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