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FDA rejects Amgen’s application for Parsabiv


THOUSAND OAKS, Calif. — The Food and Drug Administration has rejected Amgen’s application for the approval of its Parsabiv (etelcalcetide) , issuing a Complete Response Letter, the company said Wednesday. The drug is aimed at treating secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis.

“Amgen is reviewing the Complete Response Letter, and we anticipate a post-action meeting with the FDA later this year to discuss the Complete Response,” the company said, noting that this letter does not impact its regulatory submissions in other regions. 

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