FDA issues complete response letter for Rayaldee (calcifediol) as a treatment for secondary hyperparathyroidism - Opko Health Inc.

OPKO Health, Inc. announced that the FDA has issued a complete response letter (CRL) to the Company's New Drug Application (NDA) for Rayaldee (calcifediol) as a treatment for secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.

The FDA indicated in the CRL that 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 CRL did not cite any safety, efficacy or labeling issues with regard to Rayaldee, nor did it request any additional studies to be conducted prior to FDA approval. The Company's third-party manufacturer has committed to respond promptly to the FDA's observations to ensure early resolution.

In the CRL, 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.