Hi-Tech Pharmacal reports FDA and ANDA approval for generic drug used in treatment of seizures; FDA approval is company's third in 90-day period.AMITYVILLE, N.Y.--(BUSINESS WIRE)--Jan. 23, 1995--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. of Hi-Tech Pharmacal Co., Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :HITK) today announced 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. approval of an Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar (ANDA) for a generic drug used in the treatment of seizures, which is expected to generate a significant increase in annual sales. The drug, Valproic Acid Syrup USP, is the generic equivalent of Abbott Labs' Depakene Syrup, a national brand with annual sales in excess of $8 million. Seltzer noted that this new approval is the third FDA ANDA approval that Hi-Tech has received in the last 90 days. "This series of FDA approvals is gratifying. We expect a steady stream of ANDA filings going forward and are encouraged regarding timely approvals for the 16 products already on file with the FDA." Hi-Tech Pharmacal manufactures more than 75 generic over-the-counter and prescription drug products 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 H-T as well as Sooth-It brand and Diabetic Tussin brand products through its Health Care Products Division. CONTACT: Hi-Tech Pharmacal Co., Inc. Bernard Seltzer, President & CEO a/o Arthur S. Goldberg, Vice President of Finance 516/789-8228 or H.L. Lanzet, Inc. Herb Lanzet or Paul Holm, 212/687-0061 |
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