2025-18453Notice

FDA Pulls Approval on 72 Discontinued Generic Drug Applications

Published Date: 9/24/2025

Notice

Summary

The FDA is officially pulling the plug on 72 drug approvals because the companies said they stopped selling those medicines. This means those drugs won’t be available anymore, but no one’s losing money or access unexpectedly since the companies chose to stop marketing them. If you’re involved with these drugs, now’s the time to update your records and plans!

Analyzed Economic Effects

1 provisions identified: 0 benefits, 1 costs, 0 mixed.

72 Generic Drug Approvals Withdrawn

The FDA is withdrawing approval of 72 abbreviated new drug applications (ANDAs). The companies told the FDA the products were no longer marketed and asked for the approvals to be withdrawn, so those medicines will no longer be available.

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Key Dates

Published Date
9/24/2025

Department and Agencies

Department
Independent Agency
Agency
Health and Human Services Department
Food and Drug Administration
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