Treats secondary hyperparathyroidism associated with chronic kidney disease (CKD) Stage. NDA 205917, held by Hikma Pharms. Paricalcitol.
As of Nov 14, 2026, NDA 205917 (Paricalcitol), held by Hikma Pharms, was first approved by FDA on Nov 18, 2014, with 1 approved supplement and 0 published complete response letters.
Paricalcitol Injection is an active vitamin D 2 analogue indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) Stage 5.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 18, 2014 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Paricalcitol0.002MG/ML (0.002MG/ML) · solution;intravenous | Paricalcitol | Discontinued |
| Paricalcitol0.005MG/ML (0.005MG/ML) · solution;intravenous | Paricalcitol | Discontinued |
| Paricalcitol0.01MG/2ML (0.005MG/ML) · solution;intravenous | Paricalcitol | Discontinued |
| Jun 17, 2026 | Supplement 3Labeling · Standard review | Approved | |
| Nov 18, 2014 | 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
