The drug is a treatment option for people with secondary hyperparathyroidism, which causes the release of too much parathyroid hormone in the blood, and is associated with vitamin deficiency in adults with stage three or four chronic kidney disease.
About 9 million people in the U.S. deal with secondary hyperparathyroidism, according to the report. Chronic kidney failure is the most common cause for the disease.
The FDA's approval of Rayaldee is an important milestone for Opko, Dr. Phillip Frost, CEO and chairman of Opko, said in a release. He added it "is one of OPKO's many pharmaceutical products being developed for significant medical problems, which will benefit from new treatment options."
Rayaldee is the first drug of its kind to approved by the FDA, Frost said. The treatment failed to win approval in March after the FDA found deficiencies at one of the company's third-party manufacturers.
The company expects to make the drug available in the second half of this year.
Opko's stock has fallen slightly this year, down more than 3 percent.
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