BTG announces FDA review of applications for approval to market Oxandrin for delayed puberty and Turner's syndrome.ISELIN, N.J.--(BUSINESS WIRE)--Oct. 28, 1996--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 BTGC Bio-Technology General (stock symbol) BTGC Bukit Tinggi Golf Club (Malaysia) ) today announced that the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. has accepted for full review and has initiated the review process for BTG's applications for approval to market Oxandrin(R) for both the treatment of constitutional delay of growth and puberty (CDGP CDGP Citizen-Driven Government Performance CDGP Constitutional Delay in Growth and Puberty CDGP Cairns Division of General Practice (Australia) CDGP Call Data Generation Point ) in boys and Turner's syndrome, a genetic disorder in girls. CDGP and Turner's syndrome are pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. growth disorders associated with short stature. Oxandrin, an orally active testosterone analog, is beneficial in the treatment of these children. Approximately 80,000 boys and 50,000 girls in the U.S. are affected with these conditions. Oxandrin stimulates growth and the onset of puberty in boys with CDGP. Turner's syndrome is the result of a damaged or missing X chromosome in girls. Oxandrin is effective in accelerating growth in this condition. Oxandrin has been designated an Orphan Drug 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. for both CDGP and Turner's syndrome. These Orphan designations, granted to drugs for rare diseases or conditions with a prevalence of less than 200,000 cases in the U.S., will provide BTG with seven years of market exclusivity for both CDGP and Turner's syndrome, post-approval. BTG currently markets Oxandrin in the United States for the promotion of weight gain following weight loss due to severe trauma, chronic infection or extensive surgery and for the treatment of weight loss due to unknown pathophysiology. Recent treatment with Oxandrin has been shown to result in dramatic gains in weight and body cell mass in patients suffering from weight loss due to a variety of conditions, including AIDS, burns and chronic obstructive pulmonary disease chronic obstructive pulmonary disease n. Abbr. COPD A chronic lung disease, such as asthma or emphysema, in which breathing becomes slowed or forced. . In addition to the two Oxandrin filings now under review for marketing approval by the FDA, BTG's application for Premarket Approval for its ophthalmic product, BioLon(TM), which was submitted to the FDA in May 1996, is also currently under review. Further, the Company is seeking FDA approval for a sublingual sublingual /sub·lin·gual/ (-ling´gwal) hypoglossal; beneath the tongue. sub·lin·gual adj. Abbr. SL Below or beneath the tongue; hypoglossal. formulation of testosterone, Androtest-SL(R). In other news this month, BTG announced earnings of $0.07 for the third quarter of 1996 as compared with $0.01 in the third quarter of 1995. Bio-Technology General Corp. develops, manufactures and markets genetically engineered and other products for human health care. CONTACT: Investor Relations Don Weinberger Strategic Growth International 516-829-7111 or Leah Berkovits Bio-Technology General Corp. 908-632-8800 |
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