If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Oxandrin’s Applications Reviewed by FDA For Approval ISELIN, N.J., Oct. 28, 1996 -- Bio-Technology General Corp. (NASDAQ:BTGC) today announced that the United States Food and Drug Administration 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) in boys and Turner's syndrome, a genetic disorder in girls. CDGP and Turner's syndrome are pediatric 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 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. 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 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.
|
