Opko Health announced that the Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to the New Drug Application (NDA) for Rayaldee (calcifediol) as a treatment for secondary hyperparathyroidism (SHPT) in patients with Stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.
The letter included FDA’s observations of deficiencies at Opko’s third-party contract manufacturer during an FDA field inspection. The observations were not specific to Rayaldee manufacturing, and no safety, efficacy, or labeling issues regarding Rayaldee were cited. The CRL also did not request additional studies to be conducted prior to FDA approval.
Opko’s third-party manufacturer is cooperating with the FDA to ensure prompt resolution of the deficiencies cited. Despite the CRL, the FDA re-confirmed with the company the acceptance of the proprietary name Rayaldee and reached an agreement for appropriate package insert and all container labeling.
Rayaldee, an oral vitamin D prohormone, is available as extended-release capsules with a proprietary formulation designed to raise serum total 25-hydroxyvitamin D concentrations to targeted levels (≥30ng/mL) and to reduce elevated iPTH.
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