FDA Delays Approval of Opko’s Hyperparathyroidism Candidate

The FDA has put the brakes on approving Opko’s secondary hyperparathyroidism candidate Rayaldee, citing third-party manufacturer deficiencies that resulted in a Form 483.

Opko says it will work with Catalent, the third-party manufacturer, and the FDA to correct the issues. While not providing details on the Form 483, Steven Rubin, executive vice president of Opko, characterized the observations as “easily addressable,” during a conference call. He also said the observations are not specific to Rayaldee.