AMITYVILLE, N.Y.--(BUSINESS WIRE)--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 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.
