Oct. 8, 2008 - Akorn, Inc. today 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.
The details can be read here.
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