Akorn, Inc. Announces FDA Inspection Results

BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Akorn, Inc. (NASDAQ: AKRX) today announced the results from the recent FDA cGMP compliance inspection of the Decatur, IL manufacturing facility. This inspection also served as a pre-approval inspection (PAI) for Akorn’s new lyophilization operation. In correspondence received on December 20, 2007 from the Chicago District of the FDA, the FDA reported the satisfactory resolution of past cGMP issues. The District also confirmed they had reported to the FDA Center for Drug Evaluation and Research that the firm’s responses to the subject inspection appear to be acceptable. As a result of this inspection, Akorn is now eligible for pending product approvals in its ophthalmic, ampoule, liquid vial and lyophilization production filling suites in Decatur, IL.

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