FDA Does Not Approve Wyeth Contraceptive, Lybrel

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Main Category: Sexual Health / STDs
Also Included In: Women's Health / Gynecology
Article Date: 29 Jun 2006 - 10:00 PDT

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Until certain concerns are addressed the FDA will not approve Lybrel, an experimental low dose, continuous, non-cyclic combination oral contraceptive, says Wyeth. According to Wyeth, they received an 'approvable letter' from the FDA. However, they must submit more data concerning Lybrel's manufacturing process and more clinical details.

Wyeth said it will submit additional stability data regarding the Lybrel manufacturing method and additional analyses of submitted clinical data.

An 'approvable letter' generally means that approval has been postponed, not cancelled.

A meeting of contraceptive experts will take place later this year, where Wyeth scientists will be able to discuss Lybrel's clinical aspect. They are expected to review the US Pearl Index, a calculation of pregnancy rates among the study participants, bleeding patterns, plus the discontinuation rate among women in the study.

Wyeth is certain it will be able to address the FDA concerns.

Lybrel is made at Wyeth's Guyama plant, in Puerto Rico. A month ago the FDA warned Wyeth that it was concerned about quality-control issues at the plant.

Many people did not expect Lybrel to be approved until the plant problems were sorted out.

Wyeth's Statement.

Written by: Christian Nordqvist
Editor: Medical News Today
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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