Hi-Tech Pharmacal announces pending application amendment for Albuterol Sulfate Inhalation Solution 0.5% to be manufactured under sterile conditions.AMITYVILLE, N.Y.--(BUSINESS WIRE)--Nov. 6, 1996--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) has today announced that their ANDA ANDA abbr. abbreviated new drug application for Albuterol Sulfate albuterol sulfate (salbutamol sulfate) AccuNeb, Asmol (CA), Gen-Salbutamol (CA), Novo-Salmol (CA), Proventil HFA, Ventolin HFA, Vospire-ER Pharmacologic class: Sympathomimetic (beta2-adrenergic agonist) Inhalation Solution 0.5% has been amended to change the manufacturing conditions to those of complete sterility. In commenting on the amendment, 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 said, "Although Hi-Tech filed its original ANDA for Albuterol Sulfate Inhalation Solution 0.5% in Sept. 1994, 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. has since recommended that this product be manufactured under sterile conditions. As was previously announced, our new fully validated and certified state-of-the-art sterile facility is operative, giving Hi-Tech the opportunity to manufacture this product in our sterile plant." Seltzer further added, "The branded product currently marketed by Glaxo's Allen Hanburys Division, Schering Plough and its Warwick division, has sales in excess of $30 million annually. We are optimistic that if approved, we will be the first generic sterile manufacturer in the marketplace. We also expect to amend our applications for another Albuterol Sulfate product and various other products including inhalation solutions and nasal sprays currently under development in our sterile facility. We anticipate that these products will play a tremendous role in the future product development of Hi-Tech Pharmacal." 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 ointments, n.pl semisolid, non–water-based treatments that are not water-soluble and that create protective films to prevent dehydration of the skin. , 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 sterile ophthalmic and otic products as well as providing sterile manufacturing contract services. The company 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, and Steri-Optics through its Steri-Med Division. -0- This press release contains forward looking statements. Such statements involve various risks that may cause actual results to differ materially. These risks include, but are not limited to, the ability of the company to grow internally or by acquisition and to integrate acquired businesses, changing industry and competitiveness conditions and other risks referred to in the company's registration statements and periodic reports filed with the Securities & Exchange Commission. CONTACT: Hi-Tech Pharmacal, Amityville David Seltzer David Seltzer, born 1940 into a conservative Jewish[1] family in Highland Park, Illinois, is an American screenwriter, producer, and director who is perhaps best known for having written The Omen. , 516/789-8228 |
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