Application Nr Approved Date Route Status External Links
NDA021688 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 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. ( 1.1 ) 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). ( 1.2 ) 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. ( 1.3 ) 1.1 Secondary Hyperparathyroidism Sensipar Is Indicated For The Treatment Of Secondary Hyperparathyroidism (hpt) In Adult Patients With Chronic Kidney Disease (ckd) On Dialysis [see Clinical Studies ( 14.1 )]. Limitations Of Use: Sensipar Is Not Indicated For Use In Patients With Ckd Who Are Not On Dialysis Because Of An Increased Risk Of Hypocalcemia [see Warnings And Precautions ( 5.1 )] . 1.2 Parathyroid Carcinoma Sensipar Is Indicated For The Treatment Of Hypercalcemia In Adult Patients With Parathyroid Carcinoma [see Clinical Studies ( 14.2 )] . 1.3 Primary Hyperparathyroidism Sensipar Is Indicated For The Treatment Of 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 [see Clinical Studies ( 14.3 )] .

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Cinacalcet Hydrochloride CINACALCET HYDROCHLORIDE ZINC1550499

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