Skip to Content

Rayaldee Approval History

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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide