Hi-Tech Pharmacal receives FDA approval to market generic form of Tylenol with Codeine

Business Wire, May 2, 1996

AMITYVILLE, N.Y--(BUSINESS WIRE)--May 2, 1996--Hi-Tech Pharmacal has received ANDA approval from the FDA for Acetaminophen and Codeine Phosphate Oral Solution USP for the relief of mild to moderate pain, the generic form of Tylenol(R) with Codeine Oral Solution manufactured by McNeil Pharmaceutical.

In commenting on the approval, Bernard Seltzer, president and CEO, today announced, "This approval gives us an opportunity to increase our distribution into markets serving hospitals, nursing homes and other managed care facilities. We are also pleased to note that this is the seventh approval in the last 18 months. 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 19 applications on file with the FDA."

Hi-Tech Pharmacal Co., Inc. manufactures more than 100 prescription and over-the-counter generic and branded pharmaceuticals in liquid and semi-solid (creams, ointments, suppositories and gels), dosage forms, primarily for the private label market. The company also manufactures and markets its own products under the name of H-T as well as Sooth-It brand, Diabetic Tussin and DiabetiDerm and DiabetiSweet brand products through its Health Care Products Division.

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

David Seltzer, 516/789-8228