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Five captopril tentative ANDAs must await Capoten extension decision under GATT, Royce says.

Executive Summary

FIVE GENERIC CAPOTEN TENTATIVE ANDA APPROVALS MUST AWAIT FDA GATT POLICY that could extend the patent expiration date for Bristol-Myers Squibb's ACE inhibitor Capoten from Aug. 8 to February or December 1996, Royce Labs contends. Royce received tentative ANDA approval for captopril tablets March 31. Mylan and Novopharm received tentative approvals for the drug on March 22. Ciba's Geneva generics operations received the first tentative approval for captopril on Jan. 30. However, BMS' Apothecon generics operations gained full ANDA approval March 31.

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