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Generics Approvals Will Decline, US FDA Predicts, But Supplement Work May Grow

 
• By Derrick Gingery

With the pre-GDUFA backlog largely acted upon, the FDA expects ANDA approvals to decrease, but supplement actions to increase in FY 2020 and FY 2021.

Generics
Record ANDA supplement receipts pushed predictions of related actions in FY 2020 and FY 2021 to record levels. • Source: Shutterstock

A slowdown in generic drug approvals, along with a stocked application pipeline and increased supplement actions, are predicted for the next two fiscal years, suggesting a shift rather than a reduction in the US Food and Drug Administration workload.

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