Akorn, Inc announced that the US Food and Drug Administration (FDA) have granted supplemental NDA approval for IC-Green for injection, USP. This approval is Akorn's first lyophilized product approval for manufacture in its Decatur, Illinois production facility.
Akorn has invested approximately $23 million in a new liquid and lyophilized injectable manufacturing fill line at its Decatur, Illinois production facility. In December 2007, we announced the successful results of an FDA pre-approval inspection (PAI), allowing us to receive lyophilized product approvals in Decatur, and the approval of IC-Green represents a significant milestone event for Akorn.
Arthur S. Przybyl, Akorn's president and chief executive officer stated, "We are very excited to announce the FDA approval of our first Akorn-manufactured lyophilized injectable product. We intend to commercialize our lyophilization manufacturing capabilities by developing an internal ANDA injectable product line and by expanding our contract pharmaceutical manufacturing business segment to include lyophilized injectable products."
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.