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news.Akorn has announced that the FDA has granted approval for the company's abbreviated new drug application for calcitriol injection, 1mcg/mL and 2mcg/mL.
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Calcitriol injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It significantly reduces elevated levels of parathyroid hormone.
Arthur Przybyl, president and CEO of Akorn, said: “This product will be manufactured in our Decatur, IL facility, and represents the second ANDA approval received for this facility in 2008. We expect to be ready to launch Calcitriol injection in the second half of 2008.”