Rockwell Medical, Inc., a fully-integrated biopharmaceutical company, has submitted data to the US Food and Drug Administration (FDA) for approval to manufacture Calcitriol, the company's injectable active vitamin D drug.

Robert L Chioini, founder, chairman and CEO, stated, "Achieving this significant milestone is very important to our strategic initiative to begin selling drugs in the renal market. 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. We expect Calcitriol alone to generate significant additional sales and profit once launched commercially."

Calcitriol injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy. Calcitriol is the most active known form of vitamin D3 in stimulating intestinal calcium transport. Calcitriol when administered by bolus injection is rapidly available in the blood stream.

Rockwell Medical, Inc. is  a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis.