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Savient Seeks FDA Priority Review For Puricase

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Savient is seeking a six-month priority review from FDA for its gout drug pegloticase (formerly Puricase), setting it up for an action date in late April if granted. The BLA, submitted Oct. 31, could face tough safety scrutiny at FDA, however, on cardiovascular events

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