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Novartis Galvus "approvable"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Novartis will likely have to conduct another clinical trial of its dipeptidyl peptidase-4 inhibitor Galvus (vildagliptin) following a Feb. 23 "approvable" letter. FDA had earlier requested a three-month extension of the initial November 2006 user fee date due to concerns about necrotoxicity seen in preclinical studies. Novartis said FDA remains concerned about the skin toxicity and that some patients may be predisposed to achieving high plasma levels with standard doses. FDA requested that all manufacturers developing DPP-4 agents characterize their compounds' dermatologic safety profiles. Cleared in October, FDA did not see skin toxicity in Merck's Januvia (sitagliptin), which was the first DPP-4 inhibitor to be approved (1Pharmaceutical Approvals Monthly January 2007, p. 29)...

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