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Altastaph receives FDA fast track designation.
2004 MAR 31 - (NewsRx.com & NewsRx.net) -- Nabi Biopharmaceuticals (NABI) announced that the U.S. Food and Drug Administration (FDA) has determined the company's investigational product, Altastaph [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.
"We are very pleased to receive fast track designation for Altastaph," said Henrik Rasmussen, MD, PhD, Nabi Biopharmaceuticals' senior vice president of clinical, medical, and regulatory affairs. "Staph aureus infections represent a significant cause of illness and death in low birth-weight babies around the world. These babies are at a particularly high risk of developing potentially devastating infections, due in part to a poorly developed immune system, due to the lack of protection from maternal antibodies because of their premature term, and also due to the number of invasive ...
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