Jan 30, 2008 - Akorn, Inc. (NASDAQ:AKRX) today announced that the U.S. Food and Drug Administration (FDA) has granted approval for Akorn's Abbreviated New Drug Application (ANDA) for Calcitriol Injection, 1 mcg/mL and 2 mcg/mL.
Calcitriol Injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It significantly reduces elevated levels of parathyroid hormone. Annual sales for Calcitriol were approximately $6 million in 2007, according to IMS sales data.
Arthur S. Przybyl, Akorn's President and Chief Executive Officer stated, "We are pleased to announce the ANDA approval for Calcitriol Injection. 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."
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