Treats severe hypertriglyceridemia. ANDA 216798, held by Aurobindo Pharma. Fenofibrate.
As of Nov 14, 2026, ANDA 216798 (Fenofibrate), held by Aurobindo Pharma, was first approved by FDA on Sep 27, 2022, with 0 approved supplements and 0 published complete response letters.
Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia. For treatment of adult patients with severe hypertriglyceridemia. Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 27, 2022 | Original application | Approved | None posted |
| Fenofibrate54MG · tablet;oral | Fenofibrate | Rx |
| Fenofibrate160MG · tablet;oral | Fenofibrate | Rx |
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
