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Novartis Femara to conduct Phase IV interaction study with diazepam.

Executive Summary

NOVARTIS FEMARA/DIAZEPAM INTERACTION STUDY IS ONE PHASE IV COMMIT44288MENT to be initiated in first quarter 1998. The study, which will be conducted in vitro, is intended to confirm the absence of pharmacokinetic drug interaction between letrozole and diazepam. The lack of PK interaction between the two drugs was indicated by analysis of Novartis' AR/BC2 trial of Femara, upon which the Oncologic Drugs Advisory Committee based its December recommendation to approve the drug ("The Pink Sheet" Dec. 23, 1996, p. 20). Completion of the diazepam interaction study is expected by the third quarter of 1998.

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