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Approvals Cardiovascular Regulation

Portola Seeks Narrower Label For AndexXa Antidote After FDA Rebuff

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Executive Summary

Company had wanted accelerated approval for the antidote for all Factor Xa inhibitors, but will now focus the reversal agent on the two drugs commanding the largest markets – Bristol/Pfizer's Eliquis and J&J/Bayer's Xarelto.

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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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