For chronic kidney disease (CKD) on dialysis. ANDA 207008, held by Sun Pharm. Cinacalcet Hydrochloride.
As of Nov 15, 2026, ANDA 207008 (Cinacalcet Hydrochloride), held by Sun Pharm, was first approved by FDA on Oct 11, 2018, with 4 approved supplements 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). Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 11, 2018 | Original application | Approved | None posted |
| Cinacalcet HydrochlorideEQ 30MG BASE · tablet;oral | Cinacalcet Hydrochloride | Discontinued |
| Cinacalcet HydrochlorideEQ 60MG BASE · tablet;oral | Cinacalcet Hydrochloride | Discontinued |
| Cinacalcet HydrochlorideEQ 90MG BASE · tablet;oral | Cinacalcet Hydrochloride | Discontinued |
| Dec 4, 2020 | Supplement 5Labeling · Standard review | Approved | None posted |
| Dec 4, 2020 | Supplement 4Labeling · Standard review | Approved | None posted |
| May 18, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| May 18, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Oct 11, 2018 | 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
