Hi-Tech Pharmacal Receives FDA Approval to Market Generic Form of Phenergan with Codeine Phosphate Syrup

Business Wire, August 27, 1997

AMITYVILLE, N.Y.--(BUSINESS WIRE)--Aug. 27, 1997--Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) has received ANDA approval from the FDA for Promethazine Hydrochloride and Codeine Phosphate Syrup 6.25 mg/10 mg per 5 mL manufactured by Wyeth Ayerst Laboratories Inc.

In commenting on the approval, Bernard Seltzer, president and CEO today announced, "We are very pleased with this approval which should generate steady revenues and profits for Hi-Tech during the cough/cold season. This approval brings our total to 16 approvals. We are very excited about the addition of this item to our growing line of liquid and semi-solid pharmaceutical products and are confident that the approval trend will continue. We currently have 10 applications on file with the FDA with many more in development stages.

Hi-Tech Pharmacal Co., Inc. manufactures prescription and over-the-counter generic and branded pharmaceuticals in liquid and semi-solid (creams, ointments, suppositories and gels) dosage forms. The Company also manufactures sterile ophthalmic, otic, and inhalation products as well as providing sterile manufacturing contract services. The Company markets its own products under various trade names including H-T as well as Sooth-It brand, Diabetic Tussin, DiabetiDerm and DiabetiSweet brand products through its Health Care Products Division, and Steri-Optics through its Steri-Med Division.

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 those risks and uncertainties detailed in the Company's filings with the Securities and Exchange Commission, copies of which are available from the Company.

CONTACT: Hi-Tech Pharmacal Co., Inc., Amityville

David Seltzer, 516/789-8228

516/789-8429 (fax)