FDA Clears Victoza, But Warnings And More Studies Pose Hurdles
Executive Summary
That FDA's approval of Novo Nordisk's Victoza (liraglutide) uses its full cadre of FDA Amendments Act-granted drug safety controls - a Risk Evaluation and Mitigation Strategy and mandatory post-marketing requirements - is not surprising, given the concern about a potential cancer risk. But it is a disappointment to investors
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