Opko Blames Rayaldee Snub On Manufacturer
This article was originally published in Scrip
Executive Summary
Opko Health Inc. on March 30 disclosed it had received a complete response letter (CRL) from the FDA on the firm's secondary hyperparathyroidism (SHPT) drug Rayaldee (calcifediol) – blaming the snub on deficiencies with the company's third-party manufacturer, Catalent Pharma.