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Article: Nabi Biopharmaceuticals' Altastaph(TM) Receives FDA Fast Track Designation.
- Article from:
- PR Newswire
- Article date:
- March 3, 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 determined that the company's investigational product, Altastaph(TM) [Staphylococcus aureus Immune Globulin (Human)] for immediate protection against Staph aureus infections in low birth-weight infants (neonates) has received a Fast Track Designation. Fast Track Designation is a term that the FDA ascribes to certain investigational drugs that have the potential to address serious, unmet medical needs. Under this designation, the FDA commits to working closely with the developer of the product to advance it through the drug development process.
"We are very pleased to ...