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FDA Approves Combination Contraceptive Containing a Folate
Date:9/24/2010

SILVER SPRING, Md., Sept. 24 /PRNewswire-USNewswire/ -- 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).

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Levomefolate calcium is a metabolite of folic acid, a water-soluble B-vitamin that helps produce and maintain new cells in the body. A known association of low folate levels and neural tube defects (e.g., spina bifida) has resulted in recommendations that women of childbearing age supplement their diet with folate.

Beyaz is based on the approved product YAZ, which contains the same doses of estrogen and progestin, and is approved for:

  • Prevention of pregnancy
  • Treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive for contraception and
  • Treatment of moderate acne vulgaris in women at least 14 years of age, only if the patient desires an oral contraceptive for birth control.

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.

The primary efficacy study for Beyaz was a multicenter, double-blind, randomized, controlled U.S. trial in 379 healthy women age 18 to 40 who were treated with Beyaz or YAZ alone for up to 24 weeks. Beyaz was found to increase folate levels in women. In a German study of Beyaz, folate levels remained
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SOURCE U.S. Food and Drug Administration
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