Akorn, Inc. Announces First Lyophilized Product Approval For Decatur, IL: IC-Green™ For Injection, USP

Main Category: Medical Devices / Diagnostics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 10 Sep 2008 - 3:00 PDT

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Akorn, Inc. (NASDAQ: AKRX) announced that the U.S. Food and Drug Administration (FDA) has granted supplemental NDA approval for IC-Green™ for Injection, USP. This approval is Akorn's first lyophilized product approval for manufacture in its Decatur, IL production facility.

Akorn has invested approximately $23 million in a new liquid and lyophilized injectable manufacturing fill line at its Decatur, IL 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."

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 http://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. Other factors besides those listed there could also adversely affect our results.

Akorn, Inc.

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