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FDA Approves Medicines360's sNDA for Liletta (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Four Years
Posted 8 Aug 2017 by Drugs.com
August 6, 2017 – Allergan plc (NYSE:AGN), a leading global pharmaceutical company, and Medicines360, a global nonprofit women's health pharmaceutical company with a mission of expanding access to quality medicines, announced that the U.S. Food and Drug Administration (FDA) approved Medicines360’s Supplemental New Drug Application (sNDA) to extend the duration of use of Liletta (levonorgestrel-releasing intrauterine system) 52 mg for the prevention of pregnancy for up to four years. “The newly approved indication for Liletta is an important milestone in our work to make this IUD available to women, in partnership with Allergan,” said Jessica Grossman, M.D., CEO of Medicines360. “Our mission is to help women access safe and effective contraception, and the new four-year indication for Liletta is good news for women who want the reliability and flexibility that a hormonal IUD can offer.” ... Read more