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FDA to Review NDA Using Catalent Technology

OptiShell technology is delivery platform for Opko Health’s new chronic kidney disease treatment

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The U.S. Food and Drug Administration (FDA) accepted for review OPKO Health’s new drug application (NDA) for a treatment for chronic kidney disease (CKD) and vitamin D insufficiency that uses Catalent’s OptiShell softgel technology as its delivery platform. OPKO Health’s product, calcifediol modified-release capsules with the proposed trade name Rayaldee, has been developed for the prevention and treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 CKD and vitamin D...

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