Akorn, Inc. has announced that the U.S. Food and Drug Administration has granted approval for Akorn’s Abbreviated New Drug Application (ANDA) for Ciprofloxacin HCl Ophthalmic Solution USP, 0.3%. Ciprofloxacin HCl Ophthalmic Solution is indicated for the treatment of infections caused by microorganisms in corneal ulcers and conjunctivitis. Annual sales for Ciprofloxacin HCl Ophthalmic Solution are approximately $20 million, according to IMS sales data. Akorn expects to launch Ciprofloxacin in 2009. Of the 20 product approvals received in 2008, 8 were launched in 2008 and 10 are scheduled for launch in the first half of 2009.

The U.S, Food and Drug Administration has approved Akorn, Inc.’s Akten™ Ophthalmic Gel 3.5%, the first approval to an ocular anesthetic in the last 40 years. The preservative free product is stored at room temperature and can be used in any ocular applications such as cataract surgery, Lasik surgery and refractive surgery that need a topical anesthetic. This is the company’s first NDA drug product developed internally.

Akorn announced that it has received FDA approval for its Ofloxacin Ophthalmic Solution USP, 0.3%. Ofloxacin Ophthalmic Solution USP, 0.3%, is the generic version of Ophthalmic Solution to treat infections caused by bacteria in conjunctivitis and corneal ulcers. The branded drug had generated sales of approximately $7.5 million in 2007. Akorn plans to manufacture the generic drug in its Decatur, Illinois, facility, and expects to launch the drug in the third quarter of 2008.