2026-20764NoticeWallet

FDA Says LASIX Exit Wasn't Safety Fail, Generics Stay Safe

Published Date: 10/9/2026

Notice

Summary

The FDA has decided that LASIX oral solution (10 mg/mL) wasn’t taken off the market because of safety or effectiveness problems. This means generic drug makers can keep getting approval to sell their versions of LASIX, keeping options open for patients and pharmacies. No changes in price or availability are expected, so everyone who relies on this medicine can breathe easy!

Analyzed Economic Effects

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

Generics Remain Available for LASIX

The FDA determined that LASIX (furosemide) oral solution, 10 mg/mL, was not withdrawn from sale for reasons of safety or effectiveness. Because of that determination, FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this product and may continue to approve new ANDAs that refer to the product as long as they meet legal and regulatory requirements. The notice (published October 9, 2026) also states that this keeps options open for patients and pharmacies and that no changes in price or availability are expected.

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Key Dates

Published Date
10/9/2026

Department and Agencies

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