13.04.2015 15:31:05

Actavis : U.S. Availability Of LILETTA 52mg To Prevent Pregnancy For Up To 3-Yrs

(RTTNews) - Actavis plc (ACT) and Medicines360, a nonprofit women's health pharmaceutical company, announced that LILETTA (levonorgestrel-releasing intrauterine system) 52 mg is now available in the U.S. for use by women to prevent pregnancy for up to three years.

LILETTA was approved by the U.S. Food and Drug Administration on February 26, 2015, based on the largest hormonal IUD trial conducted in the U.S., ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS). LILETTA is placed in the uterus by a healthcare professional and works by continuously releasing levonorgestrel, a progestin, to prevent pregnancy.

With the availability of LILETTA, IUD-appropriate women, regardless of financial status and insurance coverage, can now access this new safe and effective IUD through Actavis and Medicines360's partnership. LILETTA is now commercially available in doctor's offices in the U.S. and through this partnership, at a lower price for public health clinics enrolled in the 340B Drug Pricing Program.

LILETTA is a small, flexible plastic T-shaped system which is 32 mm x 32 mm in size. It works to prevent pregnancy by slowly releasing levonorgestrel (LNG), a progestin, at an initial release rate of 18.6 mcg/day with an average in vivo release rate of LNG of approximately 15.6 mcg/day over a period of three years.

Generally, LILETTA can be inserted at any time if the provider is reasonably certain that the woman is not pregnant. While LILETTA is intended for use up to three years, it can be removed by a healthcare professional at any time. LILETTA can be replaced at the time of removal with a new LILETTA, if continued contraceptive protection is desired.

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