Akorn, Inc. Announces FDA Approval Of Calcitriol Injection, 1 mcg/mL And 2 mcg/mL

Akorn, Inc. recently 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 $6M 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."

About Akorn, Inc.
Akorn, Inc. manufactures and markets sterile specialty pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois and Somerset, New Jersey and markets and distributes an extensive line of hospital and ophthalmic pharmaceuticals. For more information visit www.akorn.com.

SOURCE: Akorn, Inc.