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Where A REMS Didn't Help: Sanofi Must Deal With Liver Injuries With Multaq

This article was originally published in The Pink Sheet Daily

Executive Summary

Company has sent a "Dear Dr." letter describing rare cases of liver problems and will also send additional data to FDA from the clinical trials.

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Multaq REMS May Be Revamped As Label Adds New Risks

After several years of regulatory struggles Sanofi’s anti-arrhythmic Multaq finally got to market. But results from a new study have drawn attention to safety problems in higher-risk patients and could damage the drug’s commercial opportunity.

EMA's Restriction Of Multaq Indication Could Spell Death Knell For The Drug In Europe

While giving it a positive risk/benefit balance, EMA says other anti-arrhythmic medicines should be considered before Sanofi's Multaq, potentially heralding its demise in Europe.

EMA's Restriction Of Multaq Indication Could Spell Death Knell For The Drug In Europe

While giving it a positive risk/benefit balance, EMA says other anti-arrhythmic medicines should be considered before Sanofi's Multaq, potentially heralding its demise in Europe.

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