APOMATE WINS FDA APPROVAL.Byline: Chris Sieroty Staff Writer CHATSWORTH - Shares of North American North American named after North America. North American blastomycosis see North American blastomycosis. North American cattle tick see boophilusannulatus. Scientific Inc. gained 13 percent Tuesday after the company announced that its Apomate drug had received orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the status from the U.S. Food and Drug Administration. The drug, which is currently undergoing clinical trials in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. and Europe, is intended for the noninvasive diagnosis of cardiac transplant rejection transplant rejection Graft rejection, organ rejection, tissue rejection Immunology The constellation of host immune responses evoked when an allograft tissue is transplanted into a recipient; rejection phenomena may be minimized by optimal matching of MHC antigens . ``We appreciate the thoughtful 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. of our orphan drug application and believe that the incentives provided by the orphan drug law are working well to bring new health care opportunities to patients with uncommon diseases,'' said L. Michael Cutrer, president and chief executive officer of North American Scientific, in a statement. Susan Cruzan, a spokeswoman with the FDA in Washington, explained that ``the designation is to help get drugs on the market that treat orphan conditions - in other words Adv. 1. in other words - otherwise stated; "in other words, we are broke" put differently , conditions that affect fewer than 200,000 people in any given year.'' Since the Orphan Drug Act was passed by Congress in 1982, more than 200 drugs and biological products have been brought to market, Cruzan said. Apomate is currently undergoing the second phase of clinical trials to further refine and optimize the imaging technique prior to a planned third study scheduled to begin in mid-2001, the company said. Shares of Chatsworth-based North American Scientific Inc. gained $2.50, or 13.16 percent, Tuesday to close at $21.50 on heavy volume of 36,900 shares traded on the Nasdaq exchange. |
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