FDA accepts NDA filing for AmBisome.BOULDER, Colo.--(BUSINESS WIRE)--Jan. 13, 1997--NeXstar Pharmaceuticals, 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 :NXTR) and U.S. marketing and development partner Fujisawa USA, Inc., announced today that the U.S. Food and Drug Administration (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 accepted for review the 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 ) for AmBisome, NeXstar Pharmaceuticals' liposomal formulation of amphotericin B amphotericin B (ăm'fətĕr`ĭsĭn), antibiotic that halts the growth of several disease-causing fungi. Discovered in 1956, it is produced by bacteria of the genus Streptomyces. . The FDA's acceptance of the NDA represents the Agency's opinion that the application is sufficiently complete to permit a substantive review. This action does not represent any opinion of the Agency regarding the safety, efficacy or clearance of the product. The application seeks clearance to market AmBisome for a variety of fungal disease settings. The application includes safety and efficacy data from over 1000 patients treated in 12 clinical trials. AmBisome is currently approved for the treatment of systemic, or blood-borne, fungal infections Fungal infections Several thousand species of fungi have been described, but fewer than 100 are routinely associated with invasive diseases of humans. in 25 countries. NeXstar Pharmaceuticals, Inc. is an integrated pharmaceutical company engaged in the discovery, development, manufacturing and marketing of products to treat life-threatening diseases, including cancer and infectious diseases infectious diseases: see communicable diseases. . The Company currently markets two drugs, AmBisome and DaunoXome. The Company has headquarters in Boulder, Colo.; research, development and manufacturing facilities in San Dimas, Calif.; Lakewood, Colo., and Boulder; and marketing subsidiaries worldwide. Fujisawa USA, Inc., headquartered in Deerfield, Ill., is a manufacturer of proprietary and multi-source pharmaceutical products and a subsidiary of Fujisawa Pharmaceutical Co., Ltd., based in Osaka, Japan. CONTACT: NeXstar Pharmaceuticals Inc., Boulder Katy Doherty, 303/546-7889 Fujisawa USA Inc., Deerfield Gary Schmidt, 847/317-8916 |
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