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FDA Pulls 216 Generic Drug Applications

October 26, 2021

Effective Nov. 21, the FDA is pulling the approvals of 216 abbreviated new drug applications (ANDAs) as it cracks down on drug sponsors who have failed to submit the required annual reports.

The FDA’s action comes more than 20 months after it announced a plan to withdraw nearly 250 ANDA applications from 89 drugmakers that had repeatedly failed to file annual reports for their generics.

In January 2020, the FDA issued a notice inviting the drugmakers to petition the agency for a hearing in which they could explain why their ANDA applications shouldn’t be withdrawn, warning that companies that didn’t seek a hearing would forfeit their right to later challenge the agency’s decision.

Since then, only one of the ANDA holders, Chartwell Pharmaceuticals, has requested a hearing and filed missing annual reports for three of its applications, the agency said.

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