Treats severe hypertriglyceridemia. ANDA 210606, held by Rising. Fenofibrate.
As of Nov 14, 2026, ANDA 210606 (Fenofibrate), held by Rising, was first approved by FDA on Aug 17, 2018, with 4 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 |
|---|---|---|---|
| Aug 17, 2018 | Original application | Approved | None posted |
| Fenofibrate54MG · tablet;oral | Fenofibrate | Rx |
| Fenofibrate160MG · tablet;oral | Fenofibrate | Rx |
| Jun 3, 2021 | Supplement 4Labeling · Standard review | Approved | None posted |
| May 14, 2021 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 23, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Sep 23, 2019 | Supplement 2Labeling · Standard review | Approved | None posted |
| Aug 17, 2018 | 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
