Hi-Tech Pharmacal Receives FDA Approval for Midazolam Syrup.

Business Editors

AMITYVILLE, N.Y.--(BUSINESS WIRE)--Sept. 10, 2003

Syrup Indicated For Use In Pediatric Patients

Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced today that the Company received approval from the Food and Drug Administration (FDA) to market its Midazolam Hydrochloride Syrup, 2 mg (base)/mL.

Hi-Tech's Midazolam Hydrochloride Syrup is equivalent to Midazolam HCL Syrup of Roxane Laboratories and is indicated for use in pediatric patients for sedation, anxiolysis and amnesia prior to diagnostic, therapeutic or endoscopic procedures or before induction of anesthesia.

Midazolam HCL will be marketed by We Pharmaceuticals, a specialty pharmaceutical company located in San Diego, California.

About Hi-Tech Pharmacal

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.