Lowers the risk of myocardial infarction (MI), stroke, coronary revascularization, and…. NDA 215727, held by Agepha Pharma Fz. Colchicine.
As of Nov 14, 2026, NDA 215727 (Lodoco), held by Agepha Pharma Fz, was first approved by FDA on Jun 16, 2023, with 0 approved supplements and 0 published complete response letters.
1. INDICATION AND USAGE LODOCO is indicated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease. LODOCO is an alkaloid indicated:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 16, 2023 | Original applicationNew formulation or manufacturer · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lodoco0.5MG · tablet;oral | Colchicine | RxReference drug |
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
