Hi-Tech Pharmacal Receives Tentative Approval for Dorzolamide Hydrochloride with...

Hi-Tech Pharmacal Receives Tentative Approval for Dorzolamide Hydrochloride with Timolol Maleate Ophthalmic Solution

AMITYVILLE, N.Y.--(Business Wire)--
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
dorzolamide hydrochloride with timolol maleate ophthalmic solution.
Hi-Tech's dorzolamide hydrochloride with timolol maleate ophthalmic
solution is the generic equivalent of Merck's Cosopt(R) and is
indicated for the treatment of glaucoma. According to IMS, Merck's
Cosopt(R) had sales of $334 million in 2007. The Company believes that
it has 180 days of marketing exclusivity for generic dorzolamide
hydrochloride with timolol maleate ophthalmic solution, and will begin
marketing the product upon the completion of Merck's pediatric
exclusivity period in October 2008. The Company has a partner for the
product who will share in the profits.

About Hi-Tech

Hi-Tech is a specialty pharmaceutical company developing,
manufacturing and marketing generic and branded prescription and OTC
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, 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
www.hitechpharm.com

Copyright Business Wire 2008