Opko Health Shares Tumble Following CRL Related To Rayaldee NDA

Shares of Opko Health Inc. (NYSE: OPK) were trading lower by more than 9 percent ahead of Wednesday's opening bell after the company disclosed it has received a response from the U.S. Food and Drug Administration (FDA) to its New Drug Application (NDA) for RAYALDEE.

The FDA indicated in its complete response letter that observations of deficiencies at the company's third-party contract manufacturer were issued on March 25 and were attributed to a field inspection that was initiated on March 14.

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Opko Health did however note that the FDA did not cite any safety, efficacy or labeling issues in regard to its drug, nor did it request any additional studies that need to be conducted as a pre-requisite for FDA approval.

Opko Health added that its third-party manufacturer has committed to respond promptly to the FDA's observations.

"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, M.D., chairman and Chief Executive Officer of OPKO. "We will continue to build our commercial sales organization in preparation for the earliest possible RAYALDEE launch."