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OPKO Receives CRL For RAYALDEE; Indicates Third-party Manufacturing Observations

OPKO Health Inc. (OPK) announced the U.S. FDA has issued a complete response letter to the company's New Drug Application for RAYALDEE (calcifediol) as a treatment for secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease and vitamin D insufficiency. The FDA said the observations of deficiencies at OPKO's third-party contract manufacturer were issued on March 25, 2016 as a result of an FDA field inspection initiated on March 14, 2016. The observations were not specific to RAYALDEE manufacturing.

The company said the FDA has re-confirmed the acceptance of the proprietary name RAYALDEE. The FDA also reached agreement with OPKO for an approvable package insert and all container labeling.

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