Akorn Gets First Lyo-Product Approval for Decatur Site

The FDA has granted supplemental NDA approval for Akorn, Inc.’s IC-Green for Injection, USP. This approval is Akorn’s first lyophilized product approval for manufacture in its Decatur, IL production facility.
   
The company has invested approximately $23 million in a new liquid and lyophilized injectable manufacturing fill line at its Decatur facility. In December 2007, the company announced successful results of an FDA pre-approval inspection (PAI) for lyophilized products.
   
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.”