Cinacalcet Hydrochloride

For chronic kidney disease (CKD) on dialysis. ANDA 208368, held by Dr Reddys. Cinacalcet Hydrochloride.

As of Nov 15, 2026, ANDA 208368 (Cinacalcet Hydrochloride), held by Dr Reddys, was first approved by FDA on Sep 18, 2020, with 1 approved supplement and 0 published complete response letters.

First approved: Sep 18, 2020
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Cinacalcet tablet 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 tablets are 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Sep 18, 2020	Original application	Approved	None posted

Products

3 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


May 4, 2023	Supplement 3Labeling · Standard review	Approved	None posted
Sep 18, 2020	Original application	Approved	None posted

Identifiers

Application: ANDA 208368
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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