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Akorn receives FDA approval for topical ocular anesthetic

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LAKE FOREST, Ill. — The U.S. Food and Drug Administration has approved Akorn's new drug application for Akten ophthalmic gel 3.5%, a topical ocular anesthetic agent, the company announced in a press release.

Akorn filed the new drug application in 2007 after results from a randomized, placebo-controlled, phase 3 trial involving 209 patients who met primary endpoints in all three dosing arms, according to the release.

Akorn expects to launch Akten in late October and plans to market the drug directly to hospitals and ophthalmologists, with indications for cataract surgery, refractive surgery and intravitreal injection.

Akten is the first new drug application ocular anesthetic approved by the FDA in 4 decades, according to the release.