AMITYVILLE, N.Y.--(BUSINESS WIRE)--March 30, 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 Levofloxacin Ophthalmic Solution USP, 0.5%. Hi-Tech's Levofloxacin Ophthalmic Solution USP, 0.5% is the generic equivalent of Santen's Quixin(R) Ophthalmic Solution, 0.5% indicated for the treatment of bacterial infections.
The Company filed the ANDA under Paragraph IV Certification and believes it was first to file the ANDA for the ophthalmic product. Daiichi Pharmaceutical filed a complaint against the Company in December 2003 alleging infringement of its patent which is sublicensed to Santen, seeking a permanent injunction. The Company filed an answer and counterclaim in February 2004 denying such infringement. Fact discovery is completed and no trial date has been set. The Company expects to start marketing the product pending the favorable outcome of all relevant patent litigation.
Hi-Tech is a specialty pharmaceutical company developing, manufacturing and marketing branded and generic products for the general healthcare industry. The Company specializes in difficult to manufacture liquid and semi-solid dosage forms and produces a range of sterile ophthalmic, otic and inhalation products. The Company's Health Care Products Division is a leading developer and marketer of branded prescription and OTC products for the diabetes marketplace.
Forward-looking statements (statements which are not historical facts) in this Press Release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not promises or guarantees and investors are cautioned that all forward-looking statements involve risks and uncertainties, including but not limited to the impact of competitive products and pricing, product demand and market acceptance, new product development, the regulatory environment, including without limitation, the outcome of the SEC staff's investigation and any conclusions reached by the staff which are adverse to the Company, its officers or directors, reliance on key strategic alliances, availability of raw materials, fluctuations in operating results and other results and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. These statements are based on management's current expectations and are naturally subject to uncertainty and changes in circumstances. We caution you not to place undue reliance upon any such forward looking statements which speak only as of the date made. Hi-Tech is under no obligation to, and expressly disclaims any such obligation to, update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.
Hi-Tech Pharmacal Co., Inc.
Bill Peters, 631-789-8228