Bio-Technology General Files Androtest-SL. NDA With FDA.ISELIN, N.J.--(BUSINESS WIRE)--January 14, 1997--Bio-Technology General Corp. (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 :BTGC) today announced that it has filed a new drug application ("NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ") with the U.S. Food and Drug Administration for approval to market its sublingual testosterone product, Androtest-SL., in the United States. The filing has been accepted and is now under full review by 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. . Two Phase III studies demonstrated efficacy and safety in individuals treated with BTG's sublingual sublingual /sub·lin·gual/ (-ling´gwal) hypoglossal; beneath the tongue. sub·lin·gual adj. Abbr. SL Below or beneath the tongue; hypoglossal. (under-the-tongue) testosterone. The results of these studies have been published in the Journal of Clinical Endocrinology & Metabolism. An estimated 400,000 adult males in the U.S. are hypogonadal, i.e., testosterone deficient, and could be successfully treated with testosterone therapy. However, current therapies are often inconvenient to use. Individuals treated with the injectable product must see their physician every two to three weeks for a painful, deep muscle injection which may also result in severe mood swings. Alternatives to injectable therapy are an inconvenient scrotal scrotal /scro·tal/ (skro´t'l) pertaining to the scrotum. scrotal pertaining to scrotum. scrotal abscess patch which must be applied daily or two non-scrotal patches, also applied daily, which frequently cause skin reactions at the site of application. Commenting on the NDA filing, Sim Fass, president and chief executive officer of BTG, stated: "We believe that BTG can make an important contribution to the treatment of hypogonadism Hypogonadism Definition Hypogonadism is the condition more prevalent in males in which the production of sex hormones and germ cells are inadequate. by providing a safe and effective easy-to-use testosterone therapy without the need for injections and without the skin reactions associated with patches. Through the introduction of our sublingual testosterone, we look forward to expanding the range of products that BTG markets for endocrine and metabolic disorders. Other such products marketed by BTG and its distributors are Oxandrin., for the treatment of weight loss associated with chronic infection, extensive surgery and severe trauma, and Bio-Tropin , recombinant human growth hormone human growth hormone (HGH): see growth hormone. , for the treatment of growth hormone deficient children." Bio-Technology General Corp. develops, manufactures and markets genetically engineered and other products for human health care. CONTACT: Bio-Technology General Corp. Leah Berkovits 908/632-8800 or Strategic Growth International Investor Relations Don Weinberger 516/829-7111 |
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