Syntex ganciclovir NDA

Executive Summary

Scheduled July 13 meeting of FDA's Anti-Infective Drugs Advisory Cmte. postponed at agency's request to allow further review of Syntex NDA and analysis of Burroughs Wellcome data. B-W recently discontinued its IND for ganciclovir (for cytomegalovirus in immune-compromised patients), and Syntex assumed responsibility to provide the drug to former B-W patients under the Syntex IND and compassionate-use program. Discussion of the drug has not officially been rescheduled, but the committee's next meeting is Oct. 26-27.