FDA Approves New Drug Application for RAYALDEE® to Treat Secondary Hyperparathyroidism Associated with Vitamin D Insufficiency in Stage 3-4 Chronic Kidney Disease

MIAMI–(BUSINESS WIRE)–OPKO Health, Inc. (NYSE:OPK) announced that the U.S. Food and Drug Administration (FDA) has approved RAYALDEE® (calcifediol) extended release capsules for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. RAYALDEE is a patented extended release product containing 30 mcg of a prohormone called calcifediol (25-hydroxyvitamin D3). “FDA’s approval of RA
Source: BusinessWire-Primary

FDA Approves New Drug Application for RAYALDEE® to Treat Secondary Hyperparathyroidism Associated with Vitamin D Insufficiency in Stage 3-4 Chronic Kidney Disease