{1} Receives Tentative Approval For Ofloxacin Otic Solution

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Hi-Tech Pharmacal (HITK) Receives Tentative Approval For Ofloxacin Otic Solution
5/12/2005

AMITYVILLE, N.Y.--(BUSINESS WIRE)--May 11, 2005--Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced today that the US Food and Drug Administration (FDA) has granted tentative approval to the Company's Abbreviated New Drug Application (ANDA) for Ofloxacin otic solution, 0.3%. Hi-Tech's Ofloxacin otic solution is the generic equivalent of Daiichi's Floxin(R) otic solution, 0.3% indicated for the treatment of bacterial infections of the ear which in 2004, had sales of $77 million. Floxin(R) is covered by a US patent listed in the Orange Book and currently subject to a litigation between Daiichi and Bausch & Lomb, which was first to file an ANDA on this product. If the U.S. patent listed in the Orange Book is held invalid or unenforceable, Bausch & Lomb will be granted marketing exclusivity for 180 days. Hi-Tech expects to start marketing its generic version of Floxin(R) upon expiration of this marketing exclusivity period, or upon expiration of the patent in 2012.

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