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Article: Nabi Biopharmaceuticals Receives FDA Orphan Drug Designation for Altastaph(TM); - Altastaph, Currently in Phase II Trials, is Designed to Provide Immediate Protection Against Staph aureus Infections in Low Birth-Weight Infants -.
- Article from:
- PR Newswire
- Article date:
- February 11, 2004
CopyrightCOPYRIGHT 2004 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Nabi Biopharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Nabi's investigational product, Altastaph(TM) [Staphylococcus aureus Immune Globulin (Human)] for immediate protection against Staph aureus infections in low birth-weight infants. The FDA's orphan-drug designation encourages companies to develop treatments for diseases that affect fewer than 200,000 U.S. patients, or, as in this case, for preventive drugs that will be administered to fewer that 200,000 patients per year. The designation provides potential incentives such as funding for clinical studies, study design assistance, waiver of FDA ...