Rockwell Medical, Inc. (RMTI) announced it has submitted data to the FDA for approval to manufacture Calcitriol, an injectable active vitamin D drug. Rockwell intends to launch Calcitriol as soon as it receives FDA manufacturing approval, expected in 2013.
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, the company said. Reduction of parathyroid hormone has been shown to result in an improvement in renal osteodystrophy.
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