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
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