Cinacalcet

Product manufactured by Northstar Rxllc

Application Nr Approved Date Route Status External Links
ANDA207008 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 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: 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) Hypercalcemia In Adult Patients With Primary Hpt Who Are Unable To Undergo Parathyroidectomy. (1.3) 1.1 Secondary Hyperparathyroidism Cinacalcet 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 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 Tablets Are Indicated For The Treatment Of Hypercalcemia In Adult Patients With Parathyroid Carcinoma [See Clinical Studies (14.2)] . 1.3 Primary Hyperparathyroidism Cinacalcet Tablets Are Indicated For The Treatment Of 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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