FDA approves Bayer ’ s Kyleena IUD

Bayer (ETR:BAYN) said yesterday that it won FDA approval for its hormonal contraceptive device, Kyleena, to prevent pregnancy for up to 5 years.
The German company said the long-acting reversible contraceptive (LARC) is due to hit the market next month.
LARCs are an increasingly popular form of birth control, including intrauterine devices like Kyleena. Bayer’s device slowly releases 19.5 milligrams of levonorgesterl, a hormone that thickens the lining of the womb and prevents pregnancy.
Hormonal IUDs are reportedly more effective than commonly used copper IUDs, such as Teva Pharmaceutical‘s (NYSE:TEVA) Paragard, but only slightly. Copper IUDs last longer but do not help control blood flow.
The U.S. Centers for Disease Control & Prevention report that LARCs are more effective than birth control pills or patches, and are almost as effective at preventing pregnancy as sterilization.
Kyleena adds to a suite of hormonal IUDs made by Bayer, such as Mirena and Skyla.
“With the approval of Kyleena, women have an important new birth control option that provides pregnancy prevention for up to five years,” Dr. Dario Mirski, senior vice president and head of medical affairs for the Americas at Bayer, said in prepared remarks. “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.”
“Data show that the use of ...

Source: Mass Device - September 20, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Regulatory/Compliance Women's Health Bayer HealthCare Teva Pharmaceuticals Source Type: news