Bayer's Mirena IUD gets expanded indication
This article was originally published in The Gray Sheet
Executive Summary
Bayer Healthcare's Mirena intrauterine device gains expanded FDA approval Oct. 1 to treat heavy menstrual bleeding in women who use intrauterine contraception for pregnancy prevention, making it the first IUD approved for the additional indication. Mirena, a small flexible hormone-releasing device inserted in the uterus, was approved as a contraceptive in 2000
You may also be interested in...
New EU Filings
Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Novartis Hires Ex-BMS Chief As It Pursues US Growth Strategy
The Swiss pharma company is looking to tap into the experience of ex-BMS leader Giovanni Caforio to help further it US-first commercial strategy.
Maxwellia Delivers Two UK Menstrual Health Rx-To-OTC Switches
UK switch specialist Maxwellia delivers two “me too” reclassifications in the area of women's health: Evana Heavy Period Relief and Ultravana Period Pain Relief.