Rockwell Medical updates progress on Calcitriol commercial launch
Rockwell Medical provided an update on the commercial launch of Calcitriol, stating that product stability data for manufacturing approval is suitable for submission to the FDA. The company plans to submit its chemistry, manufacturing and controls, or CMC, post-approval drug manufacturing supplement to the FDA at the end of September 2017, as guided. As a result, the company anticipates Calcitriol to be commercially available in the U.S. approximately 30 days after the CMC submission, provided the FDA has no further requests. Calcitriol is Rockwell's FDA approved active Vitamin D injection for the management of hypocalcemia in patients undergoing chronic renal dialysis.