Federal Register #2026-20764

FDA regulatory determination on LASIX furosemide oral solution

This FDA notice concerns the regulatory status of LASIX furosemide oral solution, not a government purchase. - Government agency: Food and Drug Administration (FDA), Department of Health and Human Services. - Product discussed: LASIX (furosemide) oral solution, 10 mg/mL, associated with NDA 017688. - Sanofi-Aventis U.S. LLC is identified as the NDA holder. - FDA determined the product was not withdrawn for reasons of safety or effectiveness. It will not begin procedures to withdraw approval of ANDAs referring to the product and may continue approving qualifying ANDAs that meet applicable requirements. - LASIX will remain listed in the Orange Book’s Discontinued Drug Product List. - This notice does not request products or services and is not a procurement opportunity.

Description

The FDA determined that LASIX (furosemide) oral solution, 10 mg/mL, was not withdrawn from sale for reasons of safety or effectiveness. Accordingly, FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) referring to this product. FDA may continue to approve such ANDAs if they meet applicable legal and regulatory requirements. The product will remain listed in the Orange Book’s Discontinued Drug Product List.

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