RPT-UPDATE 1-FDA OKs Bayer IUD for heavy menstrual bleeding
(Repeats to additional clients)
NEW YORK Oct 1 (Reuters) - 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 pregnancies.
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)