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Oncopeptides’ Pepaxto Withdrawal Speeds Through In 7 Months Under Expedited Procedures

 
• By Sue Sutter, Nancy Pham, and Kosh Naran

Of three accelerated approval drugs that have been ordered withdrawn to date, Pepaxto marks the shortest interval between the FDA drugs center's withdrawal proposal and the agency’s final order, suggesting that FDORA’s expedited withdrawal procedures helped move things along more quickly.

Foot race
Pepaxto marked the fastest accelerated approval withdrawal from CDER proposal to final agency order. • Source: Shutterstock

How fast is the expedited withdrawal process for accelerated approval drugs under the Food and Drug Omnibus Reform Act?

The answer is about seven months, at least for the first product to

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