Treats very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia). ANDA 202726, held by Aurobindo Pharma Ltd. Gemfibrozil.
As of Nov 13, 2026, ANDA 202726 (Gemfibrozil), held by Aurobindo Pharma Ltd, was first approved by FDA on Sep 16, 2015, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for: Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 16, 2015 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Gemfibrozil600MG · tablet;oral | Gemfibrozil | Rx |
| Dec 10, 2021 | Supplement 10Labeling · Standard review | Approved | None posted |
| Feb 19, 2019 | Supplement 6Labeling · Standard review | Approved | None posted |
| Sep 18, 2017 | Supplement 5Labeling · Standard review | Approved | None posted |
| Oct 3, 2016 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 16, 2015 | 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
