Hi-Tech Pharmacal receives FDA approval to market generic form of phenergan with dextromethorphan syrup.AMITYVILLE, N.Y.--(BUSINESS WIRE)--Aug. 7, 1996--Hi-Tech Pharmacal has received ANDA ANDA abbr. abbreviated new drug application approval from the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. for Promethazine Hydrochloride promethazine hydrochloride Avomine (UK), Phenergan, Promethacon, Promethegan, Sominex (UK), Ziz (UK) Pharmacologic class: Phenothiazine (nonselective) Therapeutic class: Antihistamine, antiemetic, sedative-hypnotic and Dextromethorphan Hydrobromide Syrup, 6.25 mg/15 mg per 5 mL, the generic form of Phenergan with Dextromethorphan Syrup 6.25 mg/15 mg per 5 mL manufactured by Wyeth Ayerst Laboratories Inc. In commenting on the approval, Bernard Seltzer, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , today announced, "We are very pleased with this approval which should generate steady revenues and profits for Hi-Tech, especially during the cough/cold season. We would also like to note that we are developing a line of Promethazine promethazine /pro·meth·a·zine/ (-meth´ah-zen) a phenothiazine derivative, used in the form of the hydrochloride salt as an antihistaminic, antiemetic, antivertigo agent, and sedative, and in the prevention and treatment of motion based liquid products and are hopeful in bringing them to market in a timely fashion. This approval brings our total to eight in less than 24 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 18 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 suppositories, n.pl solid capsules made of materials that melt at body temperature and are used to deliver medicinal substances into the rectum. 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, DiabetiDerm and DiabetiSweet brand products through its Health Care Products Division. CONTACT: Hi-Tech Pharmacal Co. Inc., Amityville David Seltzer, 516/789-8228 (phone) 516/789-8429 (fax) |
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