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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.