Healthcare Industry News: Akorn
News Release - December 21, 2007
Akorn, Inc. Announces FDA Inspection Results
BUFFALO GROVE, Ill.--(HSMN NewsFeed)--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.Arthur S. Przybyl, Akorn’s President and Chief Executive Officer stated, “We are pleased to announce the results from the latest FDA inspection of our Decatur, IL manufacturing facility. Akorn remains committed to maintaining a comprehensive and robust quality system in order to remain in compliance with current good manufacturing practice regulations. This positive result is a significant event for Akorn. The results of this recent inspection allow us to commercialize our lyophilization manufacturing capabilities. We believe a shortage of lyophilization manufacturing capacity still exists in the market place. Akorn’s mission is to manufacture and supply safe and efficacious pharmaceutical products at an affordable cost.”
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. Additional information is available at the Company’s website at www.Akorn.com.
Materials in this press release may contain information that includes or is based upon forward-looking statements within the meaning of the Securities Litigation Reform Act of 1995. Forward-looking statements give our expectations or forecasts of future events. You can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe," and other words and terms of similar meaning in connection with a discussion of future operating or financial performance. In particular, these include statements relating to future steps we may take, prospective products, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results.
Any or all of our forward-looking statements here or in other publications may turn out to be wrong. They can be affected by inaccurate assumptions or by known or unknown risks and uncertainties. Many such factors will be important in determining our actual future results. Consequently, no forward-looking statement can be guaranteed. Our actual results may vary materially, and there are not guarantees about the performance of our stock.
Any forward-looking statements represent our expectations or forecasts only as of the date they were made and should not be relied upon as representing our expectations or forecasts as of any subsequent date. We undertake no obligation to correct or update any forward-looking statements, whether as a result of new information, future events or otherwise, even if our expectations or forecasts change. You are advised, however, to consult any further disclosures we make on related subjects in our reports filed with the SEC. In particular, you should read the discussion in the section entitled "Cautionary Statement Regarding Forward-Looking Statements" in our most recent Annual Report on Form 10-K, as it may be updated in subsequent reports filed with the SEC. That discussion covers certain risks, uncertainties and possibly inaccurate assumptions that could cause our actual results to differ materially from expected and historical results. Such factors include, but are not limited to, risks and uncertainties relating to the resolution of the FDA compliance issues at our Decatur, Illinois manufacturing facility. Other factors besides those listed there could also adversely affect our results.
Source: Akorn
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