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FDA Rejects Acamprosate
July 3, 2002

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News Summary

The U.S. Food and Drug Administration (FDA) has rejected an application for a drug designed to reduce the craving for alcohol, Crain's New York Business reported July 3.

The drug, acamprosate, was developed by an affiliate of the German drug company Merck. Forest Laboratories, which was licensed to market and distribute the drug in the United States, applied to the FDA for approval.

In rejecting the drug, the FDA said that clinical trial data submitted by Forest did not demonstrate that the drug was safe and effective.

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