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news.Bayer HealthCare has gainedFDA approval for a new indication for Natazia tablets for the treatment of heavy menstrual bleeding (HMB) that is not caused by any diagnosed conditions of the uterus, in women who choose an oral contraceptive for contraception.
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The company received FDA approval for Natazia 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 30kg/m2, the company said.
The approval was based on two identically-designed, multicenter, double-blind, randomized, placebo controlled trials.
Patients with HMB who were treated with Natazia achieved a statistically significant reduction in menstrual blood loss compared with patients in the placebo group (p<0.0001 for both studies).
Bayer HealthCare vice president and US Medical Affairs head said Natazia represents a new treatment approach for appropriate women with heavy menstrual bleeding.