PipelineReview.com - Biotech News & Online Store - Akorn, Inc. Announces Tentative Approval of Diclofenac Sodium Ophthalmic Solution 0.1%

Akorn, Inc. Announces Tentative Approval of Diclofenac Sodium Ophthalmic Solution 0.1%

01 Dec 2006

Today announced that the U.S. Food and Drug Administration has granted tentative approval for Akorn’s Abbreviated New Drug Application (ANDA) for Diclofenac Sodium Ophthalmic Solution 0.1% in 2.5 ml and 5 ml dropper bottles. Final approval is expected upon expiry of patent protection for Voltaren® Ophthalmic Solution 0.1% in October 2007.

BUFFALO GROVE, IL, USA | Nov 30, 2006 | Akorn, Inc. (AMEX: AKN) today announced that the U.S. Food and Drug Administration

has granted tentative approval for Akorn’s Abbreviated New Drug Application (ANDA) for Diclofenac Sodium Ophthalmic Solution 0.1% in 2.5 ml and 5 ml dropper bottles. Final approval is expected upon expiry of patent protection for Voltaren® Ophthalmic Solution 0.1% in October 2007.

Upon final approval, Akorn’s Diclofenac Sodium Ophthalmic Solution 0.1% will be the generic equivalent of Novartis’ Voltaren® Ophthalmic Solution 0.1% indicated for the treatment of post operative inflammation in ophthalmic surgeries. The brand product had annual sales of approximately $22 million in 2005, based on IMS sales data.

Arthur S. Przybyl, Akorn’s President and Chief Executive Officer stated, “We are excited to receive this tentative approval for Diclofenac. We intend to launch this product in October 2007. This product will be manufactured in our Somerset, New Jersey facility.”

About Akorn, Inc.

Akorn, Inc., headquartered in Buffalo Grove, Illinois, develops, 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. Other factors besides those listed there could also adversely affect our results.

SOURCE: Akorn, Inc.

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