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The ABCs Of Accelerated Approval Withdrawals

 
• By Sue Sutter

At least six accelerated approval drugs have either been withdrawn or had indications revoked because confirmatory studies were not completed or failed to verify clinical benefit – including Avastin, Bexxar and Celebrex.

A handful of drugs and indications approved under FDA’s accelerated approval regulations subsequently have been withdrawn, either voluntarily or by order of the agency.

In most instances, the withdrawals resulted from the failure of required confirmatory trials to verify the drugs’ clinical benefit, but in some cases indications were revoked because confirmatory studies were...

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