Akorn, Inc. Receives NDA Approvable Letter for Akten Ophthalmic Gel 3.5%

Jun 4, 2008 - Akorn, Inc. (NASDAQ: AKRX) today announced the receipt of an FDA approvable letter for Akten(R) Ophthalmic Gel 3.5%, an ocular topical anesthetic drug product. Our approvable letter identified several minor CMC deficiencies that must be addressed and rectified before final approval is granted. The majority of these items have been addressed in our previous submissions to the FDA. The remaining response will be submitted to the FDA within the next ten days. No additional clinical data is required.

Additionally, prior to approval, product labeling must be finalized. We have received proposed labeling from the FDA and will submit final printed labeling within the next ten days.

We expect Akten(R) to be a significant revenue contributor in the second half of 2008.