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Parsabiv Approval History

FDA Approved: Yes (First approved February 7, 2017)
Brand name: Parsabiv
Generic name: etelcalcetide
Dosage form: Injection
Company: Amgen Inc.
Treatment for: Secondary Hyperparathyroidism

Parsabiv (etelcalcetide) is a calcium-sensing receptor agonist indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.

Development History and FDA Approval Process for Parsabiv

DateArticle
Feb  8, 2017Approval FDA Approves Amgen's Parsabiv (etelcalcetide) for Secondary Hyperparathyroidism in Adult Patients on Hemodialysis
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)

Further information

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