FDA Approves New Indication for Natazia Tablets
With the approval for new indication, Natazia becomes the first and only oral contraceptive indicated for the treatment of HMB.
Bayer HealthCare Pharmaceuticals Inc. announced yesterday that the U.S. 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.
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
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