Treats severe hypertriglyceridemia. ANDA 213864, held by Mankind Pharma. Fenofibrate.
As of Nov 14, 2026, ANDA 213864 (Fenofibrate), held by Mankind Pharma, was first approved by FDA on Jun 12, 2020, with 1 approved supplement and 0 published complete response letters.
Fenofibrate is 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 |
|---|---|---|---|
| Jun 12, 2020 | Original application | Approved | None posted |
| Fenofibrate54MG · tablet;oral | Fenofibrate | Rx |
| Fenofibrate160MG · tablet;oral | Fenofibrate | Rx |
| Jun 3, 2021 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jun 12, 2020 | Original application | Approved | None posted |
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
