BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Akorn, Inc. (NASDAQ: AKRX) today announced the filing of NDA 22-221 for Akten® Ophthalmic Gel 3.5%, a topical, ocular anesthetic formulation. Based on the pre-NDA meeting April 25, 2007 with the U.S. Food and Drug Administration (FDA), the dose and the overall structure of the NDA submission was finalized. The NDA was filed after a 209 randomized patient, placebo controlled clinical trial was conducted, which subsequently met the primary endpoints in all three dosing arms. Akten® is projected to be launched in the first half of 2008.
