Actavis Contraceptive Device Wins FDA Approval

By Samantha Kareen Nair and Natalie Grover

March 02, 2015

(Reuters) - The U.S. Food and Drug Administration approved a hormonal contraceptive device on Friday that gives American women another reversible contraceptive choice as effective as sterilization.

Actavis Plc holds the commercial license to the device, Liletta (levonorgestrel-releasing intrauterine system). The marketing application was submitted by non-profit pharmaceutical company Medicines360, which holds the U.S. public sector clinic rights.

The approval of Liletta was based on the largest hormonal IUD trial, ACCESS IUS, conducted in the U.S. with 1,751 enrolled women receiving the device.

Liletta was safe and effective for a broad range of women, with a cumulative three year efficacy rate of 99.45%, the company says. Liletta is approved for use for up to three years and is indicated for women regardless of parity or body mass index.

Actavis and Medicines360 expect the device to be available for use in the United States by the second quarter of 2015.


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