For chronic kidney disease (CKD) on dialysis. ANDA 210570, held by Alkem Labs Ltd. Cinacalcet Hydrochloride.
As of Nov 15, 2026, ANDA 210570 (Cinacalcet Hydrochloride), held by Alkem Labs Ltd, was first approved by FDA on May 17, 2019, with 1 approved supplement and 0 published complete response letters.
Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. Limitations of Use: Cinacalcet is not indicated for use in patients with CKD who are not on dialysis. Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). Severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy. 1.1 Secondary Hyperparathyroidism Cinacalcet are indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 17, 2019 | Original application | Approved | None posted |
| Cinacalcet HydrochlorideEQ 30MG BASE · tablet;oral | Cinacalcet Hydrochloride | Rx |
| Cinacalcet HydrochlorideEQ 60MG BASE · tablet;oral | Cinacalcet Hydrochloride | Rx |
| Cinacalcet HydrochlorideEQ 90MG BASE · tablet;oral | Cinacalcet Hydrochloride | Rx |
| Dec 4, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| May 17, 2019 | 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
