Manages secondary hyperparathyroidism and resultant metabolic bone disease. NDA 21068, held by Esjay Pharma. Calcitriol.
As of Nov 15, 2026, NDA 21068 (Rocaltrol), held by Esjay Pharma, was first approved by FDA on Nov 20, 1998, with 3 approved supplements and 0 published complete response letters.
INDICATIONS & USAGE Predialysis Patients Calcitriol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism. Dialysis Patients Calcitriol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 20, 1998 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rocaltrol1MCG/ML · solution;oral | Calcitriol | RxReference drug |
| May 15, 2013 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jul 7, 2004 | Supplement 2Labeling · Standard review | Approved | |
| Feb 1, 2002 | Supplement 1Labeling · Standard review | Approved | |
| Nov 20, 1998 | 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
