Bayer announces FDA approval of Kyleena

Kyleena will be available this month only with a prescription.
Kyleena will be available this month only with a prescription. | File photo
The U.S. Food and Drug Administration (FDA) has approved Bayer's progestin-containing intrauternine system (IUS) Kyleena for pregnancy prevention for a span of up to five years.

Kyleena will be available this month only with a prescription.

"Data show that the use of effective, long-acting birth control methods including intrauterine devices – or IUDs – have helped to reduce unintended pregnancies in the United States but we still have a long way to go," Western University of Health Sciences Obstetrics and Gynecology Professor and Chair Anita Nelson said. "Kyleena is highly effective at preventing pregnancy and may be an appropriate choice for women who want a low-dose, non-daily birth control method."

Kyleena, which is a small device in the shape of a T, contains 19.5 mg of levonorgestrel, a progestin hormone.

"With the approval of Kyleena, women have an important new birth control option that provides pregnancy prevention for up to five years," Bayer Senior Vice President and Head of Medical Affairs for the Americas Dario Mirski said. "Kyleena expands Bayer's IUD portfolio and is part of our commitment to provide women and their healthcare providers with a variety of contraceptive choices to meet their individual needs."
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