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As of Nov 14, 2026, ANDA 210248 (Fenofibrate), held by Macleods Pharms, was first approved by FDA on Nov 13, 2024, with 0 approved supplements and 0 published complete response letters.
First approved: Nov 13, 2024
Review: Standard
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Fenofibrate tablets is indicated as adjunctive therapy to diet:
to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL).
to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible. Limitations of Use
Markedly elevated levels of serum TG (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined.
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
