FDA Asks Wyeth for More Drug Data

Wyeth(WYE Quote) said Wednesday that federal regulators have delayed approving an experimental oral contraceptive that would eliminate menstrual periods.

Wyeth said the Food and Drug Administration granted conditional approval for the drug Lybrel, asking the Madison, N.J., company to send additional data regarding manufacturing methods and more information about clinical trial results that Wyeth had already filed with the agency.

The FDA will convene a panel of contraception experts to review Lybrel, the first oral contraceptive designed to eliminate periods. This committee will look at pregnancy rates among clinical-trial participants, bleeding patterns and the rates of discontinuation by women being tested, Wyeth said. ...