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Rayaldee Approval History

FDA Approved: Yes (First approved June 17, 2016)
Brand name: Rayaldee
Generic name: calcifediol
Dosage form: Extended Release Capsules
Company: OPKO Health, Inc.
Treatment for: Secondary Hyperparathyroidism

Rayaldee (calcifediol) is a vitamin D3 analog indicated for the treatment of secondary hyperparathyroidism associated with vitamin D Insufficiency in stage 3-4 chronic kidney disease.

Development History and FDA Approval Process for Rayaldee

DateArticle
Jun 21, 2016Approval FDA Approves Rayaldee (calcifediol) to Treat Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease
Apr 27, 2016FDA Accepts Resubmission of New Drug Application for Rayaldee
Mar 30, 2016OPKO Receives Complete Response Letter from FDA for Rayaldee New Drug Application
Jul 28, 2015FDA Accepts OPKO's New Drug Application for Rayaldee
Jun  2, 2015OPKO Announces Submission of Rayaldee NDA

Further information

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