FDA grants final approval for Hi-Tech Pharmacal's ANDA for levofloxacin ophthalmic solution

Feb 10 2011

Hi-Tech Pharmacal Co., Inc. (NASDAQ:HITK), a specialty pharmaceuticals company, announced today that the US Food and Drug Administration, (FDA) granted final approval for the Company's Abbreviated New Drug Application, (ANDA) for levofloxacin ophthalmic solution, 0.5% the generic for Vistakon's Quixin® ophthalmic solution, which had sales of $2 million for the 12 months ended December 2010 according to IMS sales data. The product is indicated for bacterial conjunctivitis. The Company is preparing to launch the product by the end of March 2011.

Hi-Tech currently has 15 products awaiting approval at the FDA, targeting brand and generic sales of over $1.0 billion. In addition, Hi-Tech has 20 products in active development targeting brand sales of over $2 billion, including sterile ophthalmic products, oral solutions and suspensions and nasal sprays.

SOURCE Hi-Tech Pharmacal Co., Inc.