Opportunity
Federal Register #FDA2026P4698
FDA Determination on LASIX (Furosemide) Tablets' Regulatory Status
Buyer
Food and Drug Administration
Posted
August 14, 2026
Identifier
FDA2026P4698
This notice from the Food and Drug Administration (FDA) addresses the regulatory status of LASIX (furosemide) tablets: - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - OEM Highlight: - Validus Pharmaceuticals LLC is the referenced manufacturer (NDA 016273) - Products/Drugs Mentioned: - LASIX (furosemide) tablets in 20 mg, 40 mg, and 80 mg strengths - Indicated for treatment of edema (due to congestive heart failure, cirrhosis, renal disease including nephrotic syndrome) and hypertension in adults - Key Determination: - FDA confirms these products were not withdrawn from sale for reasons of safety or effectiveness - FDA will continue to approve abbreviated new drug applications (ANDAs) for generic versions, provided all legal and regulatory requirements are met - Notable Requirements: - No procurement, purchase, or award is being announced - No specific product quantities, part numbers, or service requirements are included - The determination supports ongoing generic competition for furosemide tablets
Description
The Food and Drug Administration (FDA) has determined that LASIX (furosemide) tablets in 20 mg, 40 mg, and 80 mg strengths were not withdrawn from sale for reasons of safety or effectiveness. This determination means the FDA will not initiate procedures to withdraw approval of abbreviated new drug applications (ANDAs) referring to this drug product. The FDA will continue to approve ANDAs for this product as long as they meet legal and regulatory requirements. LASIX is indicated for treatment of edema associated with various conditions and hypertension in adults.