Parsabiv Approval Status
- FDA approved: No
- Brand name: Parsabiv
- Generic name: etelcalcetide
- Company: Amgen Inc.
- Treatment for: Secondary Hyperparathyroidism
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
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