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Akorn, Inc.
Akorn, Inc. Announces the FDA Approval of Akten Ophthalmic Gel 3.5%
October 24th, 2008
Akorn, Inc. (NASDAQ: AKRX) announced the FDA approval of NDA 22-221 for Akten(TM) Ophthalmic Gel 3.5%, a topical, ocular anesthetic formulation. The NDA was filed June 29, 2007 following the results from a randomized, placebo controlled, Phase III clinical trial in 209 subjects who met the primary endpoint in all three dosing arms (p less than 0.001). Akten(TM) is the first NDA ocular anesthetic approved by the FDA in four decades, and will be launched in October 2008. Akten(TM) is a novel, unit dose, preservative free lidocaine gel product, stored at room temperature and intended to be used in any ocular procedure that requires a topical anesthetic agent. The estimated...
Source: Health Business Week (2008-10-24)
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