FDA approves generic levofloxacin

February 23, 2011

The FDA has granted final approval to Hi-Tech Pharmacal Co. Inc. for the company's abbreviated new drug application for levofloxacin ophthalmic solution 0.5%, the generic for a proprietary ophthalmic solution (Quixin, Vistakon). The product is indicated for bacterial conjunctivitis.

Amityville, NY-The FDA has granted final approval to Hi-Tech Pharmacal Co. for the company's abbreviated new drug application for levofloxacin ophthalmic solution 0.5%, the generic version of a proprietary ophthalmic solution (Quixin, Vistakon). The product is indicated for bacterial conjunctivitis.

The proprietary ophthalmic solution had sales of $2 million for the 12 months ended in December 2010, according to IMS sales data. Hi-Tech Pharmacal is preparing to launch its generic version by the end of March 2011.

Hi-Tech Pharmacal is a specialty pharmaceutical company manufacturing generic and branded prescription and over-the-counter products. According to the company, it has 15 products awaiting approval at the FDA and targeting brand and generic sales of more than $1.0 billion, as well as 20 products in active development targeting brand sales of more than $2 billion, including sterile ophthalmic products.