Akorn, Inc. Announces FDA Approval For Unit Dose Preservative Free Tetanus Diphtheria Vaccine

Main Category: Immune System / Vaccines
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 28 Nov 2007 - 3:00 PDT

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Akorn, Inc. (NASDAQ:AKRX) announced FDA approval of a supplemental Biologics License Application (BLA) for a unit dose preservative free Tetanus Diphtheria vaccine. Akorn expects to launch this new vaccine in the first quarter of 2008.

In March 2007, Akorn announced that it had entered into an exclusive distribution agreement with Massachusetts Biologic Laboratories for Tetanus Diphtheria vaccine. Since September 2007, Akorn has been marketing a multi-dose preserved version of the Tetanus Diphtheria vaccine. This new approval will allow Akorn to effectively compete in the estimated $225 million U.S. market.

Arthur S. Przybyl, Akorn's President and Chief Executive Officer stated, "We are looking forward to launching the unit dose preservative free Tetanus Diphtheria vaccine in the first quarter of 2008. This is one of three significant near term product launches that require FDA approval. The other two products are generic oral Vancomycin capsules and Akten®, our ophthalmic NDA indicated for ocular procedures that require a topical anesthetic."

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.

Akorn, Inc