Gamma Vinyl GABA

Executive Summary

FDA's Peripheral and Central Nervous System Drugs Advisory Cmte. will review ongoing studies of Merrell-Dow's IND anticonvulsant at Oct. 18 meeting. FDA previously asked the cmte. to review animal data on the drug in May 1984. At that time, the cmte. recommended continued human testing and parallel animal toxicity studies. FDA says that Merrell-Dow has informed the agency that "interim sacrifices of monkeys have detected vacuoles." FDA is asking for another opinion from the advisory cmte. on the continuation of testing.