FDA approves Bayer contraceptive for heavy menstrual bleeding


WAYNE, N.J. — The Food and Drug Administration has approved a drug that the manufacturer called the first oral contraceptive that also treats heavy menstrual bleeding.

Bayer HealthCare Pharmaceuticals announced Wednesday the approval of Natazia (estradiol valerate and estradiol valerate and dienogest) tablets for heavy menstrual bleeding not caused by any conditions of the uterus. The drug was originally approved as an oral contraceptive in May 2010.

"Heavy menstrual bleeding is a common disorder reported by around 3 million women of reproductive age each year in the United States," Bayer HealthCare Pharmaceuticals VP and head of U.S. medical affairs Pamela Cyrus said. "As the first oral contraceptive treatment approved for heavy menstrual bleeding in women without organic pathology who choose an [oral contraceptive] for contraception, Natazia represents a new treatment approach for appropriate women with this medical condition."

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