Treats very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia). ANDA 214603, held by Ascent Pharms Inc. Gemfibrozil.
As of Nov 13, 2026, ANDA 214603 (Gemfibrozil), held by Ascent Pharms Inc, was first approved by FDA on Jan 13, 2021, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Gemfibrozil Tablets 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 |
|---|---|---|---|
| Jan 13, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Gemfibrozil600MG · tablet;oral | Gemfibrozil | 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
