Lasix tablets safe for generics, FDA confirms
Published Date: 8/14/2026
Notice
Summary
The Food and Drug Administration (FDA, Agency, or we) has determined that LASIX (furosemide) tablets, 20 milligrams (mg), 40 mg, and 80 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Generics Can Keep Using LASIX Reference
The FDA determined that LASIX (furosemide) tablets, 20 mg, 40 mg, and 80 mg, were not withdrawn from sale for reasons of safety or effectiveness. Because of this, the FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these products and will continue to approve ANDAs that refer to them as long as the applications meet legal and regulatory requirements.
Potential Labeling Update Advice for ANDAs
The FDA said that if it determines labeling for LASIX (furosemide) tablets, 20 mg, 40 mg, and 80 mg, should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. ANDA applicants may therefore need to update labeling if FDA later requires it.
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