Zavesca User Fee Goal In August; EU Review Raises Neurotoxicity Concerns

This article was originally published in Pharmaceutical Approvals Monthly

01 Jul 2003
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Pharmaceutical Approvals Monthly

Executive Summary

European review documents for Oxford GlycoSciences/Actelion’s Gaucher disease treatment Zavesca raise two concerns that are likely issues in FDA’s review: comparative efficacy to enzyme replacement therapy and neurological adverse events.

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Zavesca User Fee Goal In August; EU Review Raises Neurotoxicity Concerns

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