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Kyleena FDA Approval History

FDA Approved: Yes (First approved September 16, 2016)
Brand name: Kyleena
Generic name: levonorgestrel
Dosage form: Releasing Intrauterine System
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Birth Control

Kyleena (levonorgestrel-releasing intrauterine system) is a low-dose progestin-containing intrauterine system (IUS) indicated for the prevention of pregnancy for up to five years.

FDA approval of Kyleena was based on data from a Phase III clinical trial of 1452 generally healthy women aged 18 to 35. With a Pearl-Index of 0.29 after five years, Kyleena was more than 99 percent effective for each year of use in preventing pregnancy, and was generally well tolerated.

Kyleena is a small, soft and flexible plastic T-shaped device containing 19.5mg of levonorgestrel that is slowly released into the uterus. Kyleena provides effective birth control for up to five years, and also offers rapid return to a woman's natural level of fertility after removal.

Common side effects include vulvovaginitis, ovarian cysts, abdominal or pelvic pain, headache or migraine, acne or greasy skin, painful periods, sore or painful breasts, and increased bleeding.

Development timeline for Kyleena

Sep 19, 2016Approval FDA Approves Bayer's Kyleena (Levonorgestrel-Releasing Intrauterine System) for Prevention of Pregnancy for up to Five Years

Further information

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