(Repeats to additional clients)
NEW YORK Oct 1 The U.S. Food and Drug
Administration has approved Bayer AG's (BAYGn.DE) Mirena
intrauterine device to treat heavy menstrual bleeding in IUD
users, the company and the agency said on Thursday.
Mirena is already on the market as a contraceptive system.
The company will now be allowed to promote it for the new use
for women who choose to use IUD contraception to prevent
The product is the first contraceptive approved to treat
heavy menstrual bleeding in the United States, Bayer said.
Heavy menstrual bleeding affects between nine and 14
percent of healthy women, according to a gynecologic survey
cited by Bayer.
(Reporting by Bill Berkrot, editing by Leslie Gevirtz)