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FDA View On Amarin Disclosures Undercuts 'Same Labeling' For Biosimilars – AbbVie

This article was originally published in The Pink Sheet Daily

Executive Summary

Decision to require labeling for Zarxio that is identical to its reference product cannot be squared with agency's representation in the Vascepa off-label promotion lawsuit that failure to expressly disclose when studies were conducted using other products is misleading, petition says.

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