Akorn, Inc. Announces FDA Approval Of Diclofenac Sodium Ophthalmic Solution 0.1%

Main Category: Eye Health / Blindness
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 21 Apr 2008 - 4:00 PDT

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Akorn, Inc. (NASDAQ: AKRX) announced that the U.S. Food and Drug Administration (FDA) has granted approval for Akorn's Abbreviated New Drug Application (ANDA) for Diclofenac Sodium Ophthalmic Solution, 0.1%.

Diclofenac Sodium Ophthalmic Solution is a non-steroidal anti-inflammatory agent used to treat cataract and refractive surgery patients. Annual sales for Diclofenac Sodium Ophthalmic Solution were approximately $14 million in 2007, according to IMS sales data.

Arthur S. Przybyl, Akorn's President and Chief Executive Officer stated, "We are pleased to announce the ANDA approval for Diclofenac. This is our first product approval in 2008 for our Somerset, NJ facility, and represents another important addition to our ophthalmic product line. We expect to launch Diclofenac in the second quarter of 2008."

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.

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Akorn, Inc.