OPKO receives Complete Response Letter from FDA for Rayaldee NDA

Sole issue relates to third-party manufacturing observations.

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.

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.

"OPKO is committed to bringing Rayaldee to patients who will benefit from its intended use and will work closely with the FDA and our third-party manufacturer to ensure that the inspection observations are promptly and fully addressed," noted Phillip Frost, Chairman and Chief Executive Officer of OPKO. "We will continue to build our commercial sales organization in preparation for the earliest possible Rayaldee launch."