Sensipar

For chronic kidney disease (CKD) on dialysis. NDA 21688, held by Amgen. Cinacalcet Hydrochloride.

As of Nov 15, 2026, NDA 21688 (Sensipar), held by Amgen, was first approved by FDA on Mar 8, 2004, with 15 approved supplements and 0 published complete response letters.

First approved: Mar 8, 2004
Review: Priority
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Sensipar 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: Sensipar 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below


May 23, 2017	Supplement 23Efficacy (new indication or use) · Standard review	Approved	Letter Label Pediatric CDTL Review Pediatric Medical Review
Nov 21, 2014	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 25, 2011	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 8, 2004	Original applicationNew molecular entity · Priority review	Approved	Review Label Letter

Products

3 strengths and forms


SensiparEQ 30MG BASE · tablet;oral	Cinacalcet Hydrochloride	DiscontinuedReference drug
SensiparEQ 60MG BASE · tablet;oral	Cinacalcet Hydrochloride	DiscontinuedReference drug
SensiparEQ 90MG BASE · tablet;oral	Cinacalcet Hydrochloride	DiscontinuedReference drug

All 16 submissions, including labeling and manufacturing supplements


Dec 5, 2019	Supplement 27Labeling · Standard review	Approved	Label Letter
Mar 29, 2019	Supplement 26Labeling · Standard review	Approved	Letter Label
Mar 29, 2019	Supplement 25Labeling · Standard review	Approved	Letter Label
May 23, 2017	Supplement 23Efficacy (new indication or use) · Standard review	Approved	Letter Label Pediatric CDTL Review Pediatric Medical Review
May 15, 2017	Supplement 24Labeling	Approved	Label Letter
Nov 21, 2014	Supplement 22Labeling · Standard review	Approved	Label Letter
Nov 21, 2014	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 21, 2014	Supplement 20Labeling · Standard review	Approved	Label Letter
Aug 1, 2011	Supplement 17Labeling	Approved	Label Letter
Feb 25, 2011	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 12, 2009	Supplement 13Labeling · Standard review	Approved	Letter Label
Dec 19, 2008	Supplement 11Labeling · Standard review	Approved	Label Letter
May 2, 2008	Supplement 9Labeling · Standard review	Approved	Letter
Feb 28, 2008	Supplement 8Labeling · Standard review	Approved	Label Letter
Oct 4, 2007	Supplement 6Labeling · Standard review	Approved	Letter Label
Mar 8, 2004	Original applicationNew molecular entity · Priority review	Approved	Review Label Letter

Identifiers

Application: NDA 21688
Drugs@FDA: Overview at FDA
Company: Amgen

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