Prevents gout flares. NDA 204820, held by Hikma. Colchicine.
As of Nov 14, 2026, NDA 204820 (Mitigare), held by Hikma, was first approved by FDA on Sep 26, 2014, with 2 approved supplements and 0 published complete response letters.
Colchicine capsules are indicated for prophylaxis of gout flares in adults. Limitations of Use: The safety and effectiveness of colchicine capsules for acute treatment of gout flares during prophylaxis has not been studied. Colchicine capsules are not an analgesic medication and should not be used to treat pain from other causes.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 26, 2014 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mitigare0.6MG · capsule;oral | Colchicine | RxReference drug |
| May 16, 2024 | Supplement 6Labeling · Standard review | Approved | |
| Nov 16, 2018 | Supplement 4Manufacturing · Standard review | Approved | |
| Sep 26, 2014 | Original applicationNew dosage form · Standard review | Approved |
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
