Press Releases

Hi-Tech Pharmical Receives FDA Approval for Timolol Maleate Opthalmic Solution 0.5%

Amityville, NY, September 18, 2002 - Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced today that the Company received approval from the Food and Drug Administration to market its Timolol Maleate Opthalmic Solution 0.5%

Hi-Tech’s Timolol Maleate Opthalmic Solution 0.5% is the generic equivalent of Merck’s Timoptic® Opthalmic Solution 0.5%

David Seltzer, President and CEO of Hi-Tech commented on the news: “ We are very pleased to get the approval for Timolol Maleate Opthalmic Solution 0.5%, our first sterile opthalmic approval,which will compliment our growing line of generic products. We are committed to building a strong and competitive line of generic pharmaceuticals and have an exciting pipeline of products in development”.

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 release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 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, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission.