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Akorn, Inc. Announces First ANDA Submission for FDC Limited

18 Aug 2006

Today announced that it has submitted the first Abbreviated New Drug Application (ANDA) with the Office of Generic Drugs on behalf of FDC Limited (FDC).

BUFFALO GROVE, IL, USA | Aug 17, 2006 | Akorn, Inc. (AMEX:AKN) today announced that it has submitted the first Abbreviated New

Drug Application (ANDA) with the Office of Generic Drugs on behalf of FDC Limited (FDC). Akorn and FDC announced the signing of a purchase and supply agreement in July 2004. FDC is India's second largest manufacturer and marketer of ophthalmic pharmaceutical products. The proposed drug product is an ophthalmic solution that will be manufactured by FDC in a blow-fill-seal container closure system.

Arthur S. Przybyl, Akorn's President and Chief Executive Officer stated, "We are pleased to announce this new product submission on behalf of FDC. FDC will develop, manufacture and supply finished dosage form drug products to Akorn and we are responsible for filing FDA regulatory submissions on behalf of FDC. Akorn has exclusive U.S. marketing rights to all drug products filed on behalf of FDC."

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.

About FDC Limited

FDC Limited (Bombay Stock Exchange:FDC) manufactures ophthalmic and oral drugs in unit and multi-dose formats as well as select active pharmaceutical ingredients (API's) at a U.S. FDA-approved plant in Roha. The API's manufactured at this plant are either exported (more than 80% of the production) or formulated at the company's plants in Goa and are U.K. MHRA-approved, enabling FDC to market several products (ophthalmic and solid dosage forms) in the U.K.. Recently, FDC commissioned an additional manufacturing plant in Goa, which provides dosage form capabilities with quality systems meeting the highest International GMP Standards.

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.

SOURCE: Akorn, Inc

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