FDA Approved: RAYALDEE — Supplemental Application (OPKO Pharmaceuticals LLC)

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Summary

FDA approved a supplemental application for RAYALDEE (calcifediol) from OPKO Pharmaceuticals LLC under NDA 208010, authorizing changes to the product label.

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Diseases / indications

• Chronic Kidney Disease
• Hyperparathyroidism

Drugs mentioned

• Rayaldee (calcifediol)

Snippet

SUPPL AP for RAYALDEE (CALCIFEDIOL)