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FDA Extends Duration of Use of Liletta

Medicines360 news release; 2017 Aug 7

The FDA has approved Liletta (levonorgestrel-releasing intrauterine system) 52 mg for the prevention of pregnancy for up to 4 years. Liletta is manufactured by Allergan plc, Dublin, Ireland, and Medicines360, San Francisco, CA.

Indications: Liletta is a sterile, levonorgestrel-releasing intrauterine system indicated for prevention of pregnancy for up to 4 years.

Dosage and administration: To be inserted by a trained health care provider using strict aseptic technique. Follow insertion instructions exactly as described. Patient should be re-examined and evaluated 4 to 6 weeks after insertion and once a year thereafter, or more frequently if clinically indicated.

Adverse reactions: The most common adverse reactions reported in clinical trials (>10% users) are vaginal bacterial infections, vulvovaginal mycotic infections, and acne.

Citation:

FDA approves Medicines360’s sNDA for Liletta (levonorgestrel-releasing intrauterine system) 52 mg to prevent pregnancy for up to four years. [news release]. San Francisco, CA: Medicines360; August 7, 2017; http://medicines360.org/news/fda-approves-medicines360-s-snda-for-lilett.... Accessed August 10, 2017.