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Merrell Dow's Sabril (vigabatrin or gamma vinyl GABA)

Executive Summary

Merrell Dow's Sabril (vigabatrin or gamma vinyl GABA): Company's request to re-initiate clinical trials with the anticonvulsant drug will be reviewed Nov. 20 by FDA's Peripheral and Central Nervous System Drugs Advisory Committee. Sabril was reviewed by the committee in 1984 and again in 1985 after brain vacuoles were detected in monkeys sacrificed for a toxicity study. The committee recommended that Merrell Dow stop enrolling new human subjects in trials with the drug until it could be demonstrated that any pathological changes were reversible. Patients already on the drug were allowed to continue. Merrell Dow will submit further animal studies and additional human data obtained from foreign trials. Meeting begins at 9 a.m. in Parklawn Conference Rooms D and E.

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