Hi-Tech Pharmacal Receives Tentative Approval for Levofloxacin Oral Solution (HITK)

Hi-Tech Pharmacal Co., Inc. HITK announced today that the US Food and Drug Administration, granted tentative approval for the Company's Abbreviated New Drug Application, 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. The Company expects to receive final approval from the FDA in June 2011 when the brand's pediatric exclusivity expires related to patent number 5,053,407. Hi-Tech plans to launch in June 2011 upon receipt of final approval. The Company filed the ANDA pursuant to U.S.C. 335(j)(2)(vii)(IV) and believes that it will have 180 day exclusivity related to its Paragraph IV patent challenge.