October 10, 2008
Akorn Wins FDA Approval for Akten Ophthalmic Gel 3.5%
Akorn, a provider of sterile specialty pharmaceuticals, has received the FDA approval of NDA 22-221 for Akten ophthalmic gel 3.5%, a topical, ocular anesthetic formulation.
The new drug application (NDA) was filed on 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 (pAkten 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 major procedures include cataract surgery, refractive surgery, Lasik surgery, and intravitreal injection. Akorn has filed two US patents and one international patent on the formulation and method of use of Akten.
Arthur Przybyl, president and CEO of Akorn, said: "We expect Akten to become the standard of care whenever an ocular anesthetic is prescribed. Akten will be manufactured at our Somerset, New Jersey facility and will be marketed directly to hospitals and ophthalmologists with a targeted detail sales effort, by our 65 sales representatives."