Treats secondary hyperparathyroidism. NDA 208010, held by Eirgen. Calcifediol.
As of Nov 13, 2026, NDA 208010 (Rayaldee), held by Eirgen, was first approved by FDA on Jun 17, 2016, with 3 approved supplements and 0 published complete response letters.
RAYALDEE is a vitamin D 3 analog indicated for the treatment of secondary hyperparathyroidism in adult patients with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. Limitations of Use
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 17, 2016 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rayaldee0.03MG · capsule, extended release;oral | Calcifediol | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 19, 2024 | Supplement 13Manufacturing | Approved | |
| Dec 17, 2019 | Supplement 5Labeling · Standard review | Approved | |
| Dec 14, 2016 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jun 17, 2016 | Original applicationNew formulation or manufacturer · 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
