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Tuesday, September 28, 2010

Oral Contraceptives with Added Folate

Posted by Prahallad Panda on 6:53 AM Comments

FDA has approved addition of folate to oral contraceptives with an intent to decrease some birth defects in their babies. This is levomefolate calcium.

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FDA Approves Oral Contraceptive Containing Folate

September 24, 2010 — The US Food and Drug Administration (FDA) today approved an oral contraceptive — the first of its kind — that is intended both to prevent pregnancy and reduce the risk for neural tube defects in newborns if and when users of the pill give birth.

The approval is based on the already-approved oral contraceptive drospirenone/ethinyl estradiol (Yaz, Bayer HealthCare Pharmaceuticals), which contains the same doses of estrogen and progestin.

Like Yaz, Beyaz is approved for:

  • Preventing pregnancy

  • Treating symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to prevent pregnancy with an oral contraceptive

  • Treating moderate acne vulgaris in women at least 14 years old who desire an oral contraceptive for birth control

More information about today's FDA announcement is available on the agency's Web site.


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