FDA Yanks 14 Drugs, Spares One After Plea Deal
Published Date: 10/6/2026
Notice
Summary
The FDA fixed a previous announcement about pulling approvals for 15 generic drug applications. One drug, dimethyl fumarate capsules by Upsher-Smith Labs, will keep its approval because the company asked to keep it. This means 14 drug approvals were withdrawn as planned on June 8, 2026, but Upsher-Smith’s drug stays on the market with no extra costs or delays.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Fourteen generic drug approvals withdrawn
The FDA announced that approvals of 15 abbreviated new drug applications (ANDAs) were to be withdrawn, and the withdrawals were effective June 8, 2026. After the correction, one ANDA was preserved, which means approvals for 14 ANDAs were withdrawn as of June 8, 2026.
Dimethyl fumarate ANDA remains approved
The FDA corrected its May 7, 2026 notice to state that ANDA 210285 for dimethyl fumarate delayed-release capsules, 120 mg and 240 mg, held by Upsher-Smith Laboratories (U.S. Agent for Sawai USA, Inc.), remains approved because the company timely requested that its approval not be withdrawn. The correction removing the ANDA 210285 entry was published October 6, 2026.
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