Opko Health Inc., of Miami, said the FDA accepted the resubmission of the new drug application (NDA) for Rayaldee (calcifediol) for the treatment of secondary hyperparathyroidism in patients with stage III or stage IV chronic kidney disease and vitamin D insufficiency. The company received a complete response letter in March, in which the agency indicated deficiencies during a facility inspection of Opko's third-party manufacturer. The resubmitted NDA has a six-month review period, with a PDUFA date of Oct. 22.