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Agouron Viracept combo study press release called misleading by FDA.

Executive Summary

AGOURON VIRACEPT COMBINATION PILOT STUDY PRESS RELEASE DRAWS FDA OBJECTION that the study of Agouron's protease inhibitor Viracept (nelfinavir) with Glaxo Wellcome's Retrovir (zidovudine) and Epivir (lamivudine) is not included in Viracept labeling. "This study (study 509) was a pilot study and was not included in Viracept's labeling because it was very small and did not add meaningful information to the use of Viracept," FDA's Division of Drug Marketing, Advertising & Communications said in an April 18 letter to the company.



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