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

Business Wire, Oct 1, 1998

AMITYVILLE, N.Y.--(BUSINESS WIRE)--Oct. 1, 1998--Hi-Tech Pharmacal Co. Inc. (NASDAQ: HITK) has received ANDA approval from the FDA for Promethazine Hydrochloride Syrup USP, 6.25 mg/5 mL, equivalent to Phenergan Syrup Plain, 6.25 mg/5 mL, by Wyeth Ayerst Laboratories Inc.

This approval adds to Hi-Tech's line of Promethazine products including Promethazine HCL and Codeine Phosphate Syrup, and Promethazine HCL and Dextromethorphan Hydrobromide Syrup. The company is confident that this approval trend will continue and looks forward to receiving approvals on the exciting pipeline of new products currently in various stages of development at Hi-Tech.

Hi-Tech Pharmacal Co. Inc. is a growing manufacturer and marketer of prescription, over-the-counter and nutritional products under various brand names such as H-T and Rx Choice, as well as a broad line of branded products - Diabetic Tussin, DiabetiDerm, DiabetiSweet, Nasal Ease - designed for the diabetic and general health marketplace. These products are sold in liquid and semi-solid (creams, ointments, suppositories and gels) dosage forms. The company also is a leading manufacturer of sterile ophthalmic, otic and inhalation products and provides sterile manufacturing contract services.

This release contains forward looking statements that are subject to risks and uncertainties, including but not limited to the impact of competitive products and pricing, product demand and market acceptance, new product development, 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.