Manages secondary hyperparathyroidism and resultant metabolic bone disease. ANDA 76242, held by Hikma. Calcitriol.
As of Nov 15, 2026, ANDA 76242 (Calcitriol), held by Hikma, was first approved by FDA on Jul 18, 2003, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND 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 |
|---|---|---|---|
| Jul 18, 2003 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Calcitriol1MCG/ML · solution;oral | Calcitriol | Rx |
| Jul 3, 2006 | Supplement 1Labeling | Approved | None posted |
| Jul 18, 2003 | Original application | Approved | None posted |
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
