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Published on 31 December 2007

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FDA asks for data on bazedoxifene

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The Food and Drug Administration (FDA) has told Wyeth to answer more questions before it can rule on its experimental osteoporosis medicine.

It is fourth time since April that the regulator has rejected approval of a drug made by the company, demanded additional information, or ordered an entirely new study to be carried out.

Wyeth has received a second approvable letter for bazedoxifene from the watchdog that states it will not approve the drug for preventing postmenopausal osteoporosis until the firm explains problems with strokes and blood clots.

The FDA sent the first letter back in April asking for more information, but Wyeth’s response has not satisfied all the questions, and the FDA now wants further data.

Wyeth spokeswoman Natalie de Vane said the company will continue to work with the FDA on issues surrounding other rejected drugs.

The FDA has already rejected an experimental schizophrenia drug, bifeprunox, claiming it is not as effective as other drugs on the market, something Wyeth disputes.

Ms De Vane said the firm and its partner Solvay Pharmaceuticals are discussing the drug’s prospects with the regulator, but could not say whether an additional study will be needed.

Copyright © PA Business 2007

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