AstraZeneca Says Andexxa Will Not Convert To Full Approval, Quietly Reveals Complete Response

Whether the FDA will seek withdrawal of the anticoagulant-reversal agent or request additional confirmatory data is unclear.

Rock climber dangling over edge of mountain trying to get up.
AstraZeneca's Andexxa is the latest product cleared through accelerated approval to remain dangling after failing to convert to full approval. (Shutterstock)

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