Posted by Michael Wonder on 24 Aug 2016
Amgen provides update on status of Parsabiv (etelcalcetide) new drug application submitted to the U.S. FDA
24 August 2016 - Amgen today announced that the U.S. FDA has issued a complete response letter for the new drug application for Parsabiv (etelcalcetide) for the treatment of 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 complete response letter does not impact our regulatory submissions in other regions.
