FDA accepts Opko's resubmitted Rayaldee NDA

Opko Health Inc. (NYSE:OPK; Tel Aviv:OPK) said FDA accepted for filing a resubmitted NDA for Rayaldee calcifediol to treat secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency. Its PDUFA date is Oct. 22.

Last month, FDA issued a complete response letter for the modified-release formulation of 25-hydroxyvitamin D, which Opko said was solely related to deficiencies that were not specific to Rayaldee at the company's third-party contract manufacturer. ...