Application Nr Approved Date Route Status External Links
ANDA204377 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Cinacalcet Is A Calcium-Sensing Receptor Agonist Indicated For: Secondary Hyperparathyroidism (Hpt) In Adult Patients With Chronic Kidney Disease (Ckd) On Dialysis. ( 1.1 ) 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). ( 1.2 ). Severe Hypercalcemia In Adult Patients With Primary Hpt Who Are Unable To Undergo Parathyroidectomy. ( 1.3 ) 1.1 Secondary Hyperparathyroidism Cinacalcet Hydrochloride Tablets Are 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: Cinacalcet Hydrochloride Tablets Are 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 Cinacalcet Hydrochloride Tablets Are Indicated For The Treatment Of Hypercalcemia In Adult Patients With Parathyroid Carcinoma [See Clinical Studies ( 14.2 )] . 1.3 Primary Hyperparathyroidism Cinacalcet Hydrochloride Tablets Are Indicated For The Treatment Of Severe Hypercalcemia In Adult Patients With Primary Hpt 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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