30 March 2016 - OPKO Health announces that the U.S. FDA has issued a complete response letter (CRL) to the company's new drug application for Rayalde (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 25 March 2016 as a result of an FDA field inspection initiated on 14 March 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.

For more details, go to: http://investor.opko.com/releasedetail.cfm?ReleaseID=962607