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U.S. FDA Approves First and Only Oral Contraceptive Demonstrated to Treat Heavy Menstrual Bleeding (HMB)
Date:3/14/2012

WAYNE, N.J., March 14, 2012 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Natazia® (estradiol valerate and estradiol valerate/dienogest) tablets for the treatment of heavy menstrual bleeding (HMB) that is not caused by any diagnosed conditions of the uterus (womb), in women who choose an oral contraceptive (OC) for contraception.  With this approval, Natazia is the first and only oral contraceptive indicated for the treatment of HMB.

Natazia was approved in May 2010 for the prevention of pregnancy.  The contraceptive efficacy of Natazia has not been evaluated in women with a body mass index (BMI) greater than 30 kg/m2.

"Heavy menstrual bleeding is a common disorder reported by around three million women of reproductive age each year in the United States[1]," said Pamela A. Cyrus, M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals.  "As the first oral contraceptive treatment approved for heavy menstrual bleeding in women without organic pathology who choose an OC for contraception, Natazia represents a new treatment approach for appropriate women with this medical condition."

Recognized signs of HMB may include menstrual flow that soaks through one or more sanitary pads or tampons every hour, the need to use double sanitary protection to control heavy flow, or the need to wake up to change sanitary protection during the night.[2]

About the HMB Clinical Program for Natazia

The approval of Natazia for this HMB indication was based on two identically-designed, multicenter, double-blind, randomized, placebo controlled trials – one in North America and one in Europe and Australia.  The studies included a total of 421 women, who were 18 years of age or older, with a diagnosis of dysfunctional uterine bleeding characterized as heavy,
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SOURCE Bayer HealthCare Pharmaceuticals Inc.
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