Federal Register #FDA-2026-P-0655

FDA Regulatory Determination on FENOGLIDE (Fenofibrate) Tablets

This FDA notice provides a regulatory update on FENOGLIDE (fenofibrate) tablets: - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEM Highlight: - Salix Pharmaceuticals, Inc. is the NDA holder and manufacturer of FENOGLIDE - Products Mentioned: - FENOGLIDE (fenofibrate) tablets, 40 mg and 120 mg - Key Details: - FDA determined FENOGLIDE was not withdrawn for safety or effectiveness reasons - The drug remains listed in the Discontinued Drug Product List for reasons other than safety or effectiveness - ANDAs referencing FENOGLIDE may continue to be approved if they meet all legal and regulatory requirements - Notice is informational for generic drug applicants; no procurement or purchase is being solicited - Notable Requirements: - No products or services are being requested; the notice clarifies regulatory status for future generic applications - Location: - FDA headquarters in Silver Spring, MD is the relevant federal office

Description

The Food and Drug Administration (FDA) has determined that FENOGLIDE (fenofibrate) tablets, 40 mg and 120 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination allows FDA to continue approving abbreviated new drug applications (ANDAs) referring to this drug product as long as they meet legal and regulatory requirements. The drug was discontinued by Salix Pharmaceuticals but remains listed in the Discontinued Drug Product List for reasons other than safety or effectiveness. The FDA reviewed relevant data and found no evidence suggesting withdrawal due to safety or effectiveness concerns.

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