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

 
• By Sarah Karlin-Smith

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)
Key Takeaways
  • Andexxa will not convert to a full approval after the US FDA sent AstraZeneca a complete response letter, but it is unclear whether the agency will try to withdraw the drug from the market.

AstraZeneca PLC’s anticoagulant reversal agent Andexxa (andexanet) will not convert to full approval, the company told the Pink...

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Real-Time Release Of CRLs Is US FDA’s Goal, Agency Leaders Affirm

 
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