FDA GATT POLICY PREVENTS ANDA APPROVALS DURING EXTENDED PATENT PERIOD: NEW INFO DUE AT FDA BY JULY 8; CAPOTEN, ZANTAC WILL BE PROTECTED PAST 1995
Executive Summary
Drug companies must submit new patent information on extensions from GATT to FDA by July 8 to prevent generic approvals during extended patent periods established by implementing legislation for the General Agreement on Tariffs & Trade, according to FDA Deputy Commissioner for Policy William Schultz in a May 25 response to a March 7 Glaxo citizen's petition.