Bayer AG (BYR.L,BAYRY.PK,BAYZF.PK) said the U.S. Food and Drug Administration, or FDA, has approved a new indication for Natazia (estradiol valerate and dienogest) tablets for the treatment of heavy menstrual bleeding, or HMB, that is not caused by any diagnosed conditions of the uterus (womb), in women who choose to use a combined oral contraceptive for contraception.
The company noted that with the above approval, Natazia is the first and only combined oral contraceptive indicated for the treatment of heavy menstrual bleeding in the U.S.
Dr. Flemming Ornskov, Head of Strategic Marketing General Medicine at Bayer HealthCare Pharmaceuticals, said, "As the first combined oral contraceptive treatment for heavy menstrual bleeding, Natazia represents a non-invasive treatment approach for this medical condition in addition to our intrauterine system Mirena. Both products underline Bayer's ongoing commitment to advancing women's health by providing them with multiple treatment options."
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