Treats secondary hyperparathyroidism (HPT). NDA 208325, held by Kai Pharms Inc. Etelcalcetide.
As of Nov 13, 2026, NDA 208325 (Parsabiv), held by Kai Pharms Inc, was first approved by FDA on Feb 7, 2017, with 3 approved supplements and 0 published complete response letters.
PARSABIV is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. PARSABIV is a calcium-sensing receptor agonist indicated for: Secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. Limitations of Use: PARSABIV has not been studied in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or with CKD who are not on hemodialysis and is not recommended for use in these populations.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 7, 2017 | Original applicationNew molecular entity · Standard review | Approved |
| Parsabiv2.5MG/0.5ML (2.5MG/0.5ML) · solution;intravenous | Etelcalcetide | RxReference drug |
| Parsabiv5MG/ML (5MG/ML) · solution;intravenous | Etelcalcetide | RxReference drug |
| Parsabiv10MG/2ML (5MG/ML) · solution;intravenous | Etelcalcetide | RxReference drug |
| Feb 11, 2021 | Supplement 5Labeling · Standard review | Approved | |
| Mar 8, 2019 | Supplement 2Labeling · Standard review | Approved | |
| Aug 20, 2018 | Supplement 1Labeling · Standard review | Approved | |
| Feb 7, 2017 | Original applicationNew molecular entity · 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
