April 18, 2008 - Akorn, Inc. (NASDAQ: AKRX) today 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."
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