FDA Says Bye-Bye to Fenoglide, But Not for Bad Reasons
Published Date: 4/30/2026
Notice
Summary
The FDA has confirmed that FENOGLIDE tablets (40 mg and 120 mg) were not taken off the market because of safety or effectiveness problems. This means generic drug makers can keep getting approval to sell their versions, keeping options open for patients and pharmacies. No changes in cost or availability are expected, so everyone can breathe easy and keep using these meds as usual.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Fenoglide Allowed for Generic Approvals
The FDA determined that FENOGLIDE (fenofibrate) tablets, 40 mg and 120 mg, were not withdrawn from sale for reasons of safety or effectiveness in a notice published April 30, 2026. Because of that finding (NDA 022118, initially approved August 10, 2007), the FDA will not start procedures to withdraw approvals of abbreviated new drug applications (ANDAs) that refer to FENOGLIDE and will continue to approve new ANDAs that refer to the product if they meet legal and regulatory requirements.
Possible Labeling Updates for ANDA Applicants
The FDA said it may require labeling revisions for FENOGLIDE (fenofibrate) tablets and will advise ANDA applicants to submit updated labeling if the Agency determines labels should be revised to meet current standards. Salix Pharmaceuticals notified FDA of the product discontinuation on September 9, 2024, and the Agency reviewed records before making its April 30, 2026 determination.
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