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Indevus Sanctura Comparative Claims Not Supported By NDA, FDA Finds

This article was originally published in 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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FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011

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