Amgen Inc.'s hyperparathyroidism treatment Parsabiv failed to receive FDA approval.
The Food and Drug Administration issued a complete response letter (CRL) for Parsabiv (etelcalcetide), the company said in an Aug. 24 press release. The FDA issues a CRL when it has finished its review of an application but has questions that preclude approval.
Amgen is seeking approval of the drug for treating secondary hyperparathyroidism in adults with chronic kidney disease on hemodialysis.
The company submitted the new drug application for Parsabiv to the FDA in August 2015 13 PLIR 1262, 8/28/15.
Meeting With FDA.
Amgen said it is reviewing ...
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