Akorn, Inc. Announces the FDA Approval of Akten(TM) Ophthalmic Gel 3.5%

LAKE FOREST, Ill., Oct 08, 2008 (BUSINESS WIRE) -- Akorn, Inc. (AKRX:
AKRX 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<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 market size for Akten(TM) is approximately eleven million procedures annually. The major procedures include cataract surgery, refractive surgery, Lasik surgery, and intravitreal injection. Akorn has filed two United States patents and one International patent on the formulation and method of use of Akten(TM).

source: MarketWatch