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FDA Delays Approving 365-Day-A-Year Pill

Posted on: Wednesday, 28 June 2006, 21:00 CDT

WASHINGTON - Health officials have delayed approving a new birth-control pill that can stop many women from menstruating when taken without interruption throughout the year, its manufacturer said Wednesday.

Wyeth had hoped the Food and Drug Administration would approve Lybrel on Tuesday, following a previous extension of the review period for the pill.

Instead, the FDA delayed action, saying it wanted more data on how the company's proposed manufacturing method for the pill affects its shelf life, Wyeth said. The agency also seeks more information on the pregnancy rates, bleeding patterns and dropout rates of participants in studies of the pill, according to the Madison, N.J.-based company.

The FDA plans a public meeting this year to discuss the pill, Wyeth said. That is an apparent reference to a meeting of one of the outside panels of experts the regulatory agency relies on for advice.

If ultimately approved, Lybrel would become the first birth-control pill meant to be taken by women 365 days a year, without breaks or sugar pills. In clinical trials, 70.8 percent of women were period-free by their seventh month on the pill, though some still experienced breakthrough bleeding or spotting, according to Wyeth. The trials suggested the pill was 98 percent effective in preventing pregnancies.

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On the Net:

Food and Drug Administration: http://www.fda.gov/

Wyeth: http://www.wyeth.com/

Source: Associated Press/AP Online

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