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Medicines360: FDA Approves Extended Duration Of Use For LILETTA

Medicines360 and Allergan plc (AGN) announced the U.S. FDA has approved Medicines360's Supplemental New Drug Application to extend the duration of use of LILETTA 52 mg for the prevention of pregnancy for up to six years. LILETTA is a hormone-releasing system placed in a woman's uterus to prevent pregnancy. Medicines360 noted that the approval marks the longest approved duration of use of any hormonal intrauterine devices.

Medicines360 received initial approval of LILETTA in 2015. Since then, Medicines360 and Allergan have continued to invest in the product. LILETTA is available at a lower cost to public health clinics enrolled in the 340B Drug Pricing Program.

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