2026-09011NoticeWallet

FDA Greenlights Generics for MICARDIS Blood Pressure Pills

Published Date: 5/7/2026

Notice

Summary

The FDA has decided that MICARDIS tablets (20 mg and 80 mg) were not taken off the market because of safety or effectiveness problems. This means generic versions can keep getting approved, helping patients access affordable options without delays. If you use or make these meds, no sudden changes or extra costs are coming your way anytime soon!

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Analyzed Economic Effects

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

MICARDIS Generics Can Continue

The FDA determined on May 7, 2026 that MICARDIS (telmisartan) tablets, 20 mg and 80 mg, were not withdrawn from sale for reasons of safety or effectiveness. Because of this, FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these products and may continue approving new ANDAs that refer to these products so long as they meet legal and regulatory requirements. MICARDIS (NDA 020850, originally approved November 10, 1998) will remain listed in the Orange Book’s “Discontinued Drug Product List.”

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Key Dates

Published Date
5/7/2026

Department and Agencies

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