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Parsabiv Approval Status

Parsabiv (etelcalcetide) is a novel calcimimetic agent in clinical development for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on hemodialysis.

In August 2016, Amgen Inc. announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for Parsabiv (etelcalcetide).

Development Status and FDA Approval Process for Parsabiv

DateArticle
Aug 24, 2016Amgen Provides Update on Status of Parsabiv (Etelcalcetide) NDA Submitted to the U.S. FDA
Nov  6, 2015FDA Accepts Amgen's New Drug Application For Novel Intravenous Calcimimetic Etelcalcetide
Aug 25, 2015Amgen Submits New Drug Application For Novel Intravenous Calcimimetic Etelcalcetide (AMG 416)

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