• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

FDA approves Bayer’s Kyleena IUD

September 20, 2016 By Sarah Faulkner

Bayer logoBayer (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 effective, long-acting birth control methods including intrauterine devices – or IUDs – have helped to reduce unintended pregnancies in the U.S., but we still have a long way to go,” added Dr. Anita Nelson from Western University of Health Sciences. “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.”

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Women's Health Tagged With: Bayer HealthCare, Teva Pharmaceuticals

IN CASE YOU MISSED IT

  • Embecta stock soars on first full-quarter results after BD spinoff
  • Abbott will spend $450M to up FreeStyle Libre production in Ireland
  • Better Therapeutics Q2 beats Street as it prepares to submit diabetes therapy for FDA review
  • Study backs Fluidx embolic device for vessel filling
  • Senseonics stock is up as it sticks by revenue guidance

Primary Sidebar

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Drug Delivery Business News in a minute? We Deliver!
Drug Delivery Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Signup for the newsletter

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing & Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts
Add us on FacebookFollow us on TwitterConnect with us on LinkedIn

Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS