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FDA's Victoza Decision BalancedUnknown Cancer Risk Against Known FDAAA Measures

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA’s approval of Novo Nordisk’s type 2 diabetes drug Victoza (liraglutide) was a bit surprising for an agency often seen as increasingly conservative, even given that the Jan. 25 decision came with extensive labeling, risk management and mandatory post-market studies focused on the cancer risk.

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