Hi-Tech Pharmacal Receives Final Approval for Levofloxacin Oral Solution

Hi-Tech Pharmacal Co., Inc. HITK announced today that the US Food and Drug Administration, (FDA) granted final approval for the Company's Abbreviated New Drug Application, (ANDA) for levofloxacin oral solution 25mg/mL, the generic for McNeil Pharmaceutical's Levaquin® oral solution which had sales of $6 million for the 12 months ended December 2010 according to IMS sales data. The product is indicated for the treatment of adults with mild, moderate and severe infections. Hi-Tech plans to launch the product immediately. The Company filed the ANDA pursuant to 505(j)(2)(A)(vii)(IV) of the Food Drug and Cosmetic Act and the FDA confirmed that Hi-tech will have 180 day exclusivity related to its Paragraph IV patent challenge. Hi-Tech currently has 13 products awaiting approval at the FDA, targeting brand and generic sales of over $1 billion. In addition, Hi-Tech has 20 products in active development targeting brand sales of over $4 billion, including sterile ophthalmic products, oral solutions and suspensions and nasal sprays.