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Akorn receives approvable letter from FDA for topical ocular anesthetic

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BUFFALO GROVE, Ill. — Akorn has received an approvable letter from 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.

The letter identified several minor chemistry, manufacturing and controls (CMC) deficiencies that must be resolved in order to receive final FDA approval. However, Akorn has addressed the majority of these items in previous submissions to the FDA, and no additional clinical data is necessary, according to the release.

Akorn plans to submit a response regarding these deficiencies and final printed product labeling for the drug within the next 10 days.

The company expects the new ocular anesthetic to increase revenues in the second half of 2008, the release said.