Oral Contraceptives
Wyeth receives approvable letter from U.S. FDA for combination oral contraceptive
Published in Medical Letter on the CDC and FDA, July 30th, 2006
In response to the approvable letter, Wyeth will submit additional stability data regarding the Lybrel manufacturing method and additional analyses of submitted clinical data. The agency also indicated that it plans to convene a public meeting of contraceptive experts this year to discuss the clinical aspects of Lybrel.
The anticipated topics include a review of the U.S. Pearl Index (a calculation of the...
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