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Akorn files new drug application with FDA for topical ocular anesthetic

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BUFFALO GROVE, Ill. — Akorn has filed a new drug application with the U.S. Food and Drug Administration for Akten ophthalmic gel 3.5%, a topical ocular anesthetic formulation, the company announced in a press release.

Akorn filed the application after completing a randomized, controlled trial involving 209 patients that met its primary endpoints in all three dosing arms. Company officials expect to launch the drug in the first half of 2008, the release said.

Akten represents Akorn's first internally developed NDA drug product, which the company plans to market directly to ophthalmologists for use in such procedures as cataract surgery, LASIK and other refractive surgeries, and during intravitreal drug injections, according to the release.

A generic name for the drug was not provided in the press release.