Rockwell Medical, 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 replacement, secondary hyperparathyroidism and hemodialysis, announced that the FDA has approved the Company's Supplemental Abbreviated New Drug Application (sANDA) to manufacture Calcitriol. Calcitriol is Rockwell's low-cost generic active vitamin D drug.
"Achieving this FDA approval is a significant achievement for Rockwell and it enables us to execute on our strategic initiative to begin selling Calcitriol in the renal market, where the CMS bundled-reimbursement payment system has incentivised dialysis service providers to utilise the lowest cost drugs," stated Mr. Robert L. Chioini, founder, chairman and chief executive officer of Rockwell. "Importantly, Rockwell's Calcitriol injection is the only one available packaged in vials, which is the standard of care, and it is equivalent in safety and efficacy to the branded vitamin D drugs. Furthermore, 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."
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.