Tuesday, September 28, 2010

FDA approves Beyaz tablet (combination contraceptive containing a folate)

The U.S. Food and Drug Administration today approved Beyaz tablets, an estrogen/progestin combined oral contraceptive that also contains a folate (levomefolate calcium 0.451 mg).

In addition to the approved YAZ indications, Beyaz also is approved for the secondary indication in women who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product.

Beyaz is manufactured by Bayer HealthCare Pharmaceuticals Inc., the U.S.-based business arm of Bayer HealthCare LLC, a subsidiary of Bayer AG.

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