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Rockwell submits injectable active vitamin D drug manufacturing data to FDA

Rockwell Medical has submitted the manufacturing data of Calcitriol, an injectable active vitamin D drug formulation, to FDA for approval.

Rockwell founder, chairman and CEO Robert Chioini said, "Coupled with the considerable clinical progress we continue to make with our iron-delivery drug SFP, we believe Rockwell is uniquely positioned for dynamic sales growth in the hemodialysis market."

Calcitriol injection, proven to reduce high parathyroid hormone levels, is indicated for the management of hypocalcemia in patients undergoing chronic renal dialysis.

The most active known form of vitamin D3 stimulates intestinal calcium transport.

Upon administration by bolus injection, Calcitriol will be swiftly available in the blood stream.