Rockwell Medical Inc. (RMTI) announced that the FDA has approved the company's Supplemental Abbreviated New Drug Application or sANDA to manufacture Calcitriol. Calcitriol is Rockwell's low-cost generic active vitamin D drug.
".......our long-standing commercial presence in the hemodialysis market, built via our successful concentrate business, has enabled us to develop strong relationships with our customers. We believe Rockwell is uniquely positioned to generate dynamic sales growth by offering the dialysis market the original, low-cost generic vitamin D injection in vials. We are targeting commercial launch for year end," said Robert Chioini, Founder, Chairman and Chief Executive Officer of Rockwell.
The company noted that Calcitriol (active vitamin D) 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 when administered by bolus injection is rapidly available in the blood stream.
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