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FDA clears Bayer's birth control pill

The US FDA has approved Bayer's Beyaz, a version of the company's combination pill YAZ that also contains levomefolate calcium

The US Food and Drug Administration (FDA) has approved Bayer's Beyaz oral contraceptive tablets, a version of the company's estrogen/progestin combination pill YAZ. As well as including the active ingredients found in YAZ, Beyaz also contains a folate to reduce the risk of a neural tube defect in pregnancies that occur while women are taking the product or soon after they discontinue use.

Beyaz contains the same level of estrogen and progestin as the original YAZ, which was launched in 2006 in the US and is the only birth control pill indicated to treat premenstrual dysphonic disorder (PMDD). The added active ingredient in Beyaz, levomefolate calcium, is a metabolite of the water-soluble B-vitamin folic acid.

The new product, like YAZ, is indicated for prevention of pregnancy; treatment of PMDD in women who choose to use an oral contraceptive for contraception; and treatment of moderate acne in women at least 14 years of age who choose to use an oral contraceptive for birth control.

The approval was based on a US trial that enrolled 379 healthy women aged 18 to 40 who received either Beyaz or YAZ for up to 24 weeks. Subjects taking Beyaz were found to have higher folate levels than those taking YAZ. A separate German study showed that folate levels remained elevated for several weeks after women stopped taking the pill, according to Bayer.

Previous clinical trials of YAZ were used to establish safety and efficacy for Beyaz for the contraception, PMDD, and acne indications.

27th September 2010

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