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BioPharmaceutical

Indevus Sanctura Comparative Claims Not Supported By NDA, FDA Finds

This article was originally published in Pharmaceutical Approvals Monthly

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  • Pharmaceutical Approvals Monthly

Executive Summary

Indevus’ NDA for Sanctura did not support a claim that trospium has a superior central nervous system adverse event profile to other anticholinergics, FDA review documents indicate.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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