Akorn announces FDA approval of two solutions

Buffalo Grove, IL-Akorn Inc. has received FDA approval of its abbreviated new drug applications for 0.1% diclofenac sodium ophthalmic solution and 0.3% ofloxacin ophthalmic solution USP.

Diclofenac is a non-steroidal anti-inflammatory agent used to treat patients undergoing cataract and refractive surgery. Annual sales for the solution were approximately $14 million in 2007, according to IMS sales data.

“This is our first product approval in 2008 for our Somerset, NJ, facility,” said Arthur S. Przybyl, Akorn’s president and chief executive officer. The company expects to launch diclofenac in the second quarter of this year, he added.

Ofloxacin is an anti-infective used to treat infections caused by bacteria in conjunctivitis and corneal ulcers. Annual sales for the solution were approximately $7.5 million in 2007, according to IMS sales data.

The ofloxacin solution will be manufactured in the company’s Decatur, IL, facility, said Przybyl, who added that the company plans to launch the product in the third quarter of this year.