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Victoza Clears European Regulators Without Thyroid Cancer Restrictions

Executive Summary

NovoNordisk is facing a much easier path for Victoza (liraglutide) in Europe than the rocky road the type 2 diabetes therapy is on in the U.S

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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

FDA Clears Victoza, But Warnings And More Studies Pose Hurdles

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

FDA Clears Victoza, But Warnings And More Studies Pose Hurdles

Liraglutide's US approval comes with a black box warning for a thyroid cancer risk and hefty post-marketing requirements.

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