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Biopure Files for FDA Approval of Blood Substitute Hemopure
Biopure Corp. announced Tuesday that the FDA has accepted its application for approval of its blood substitute, Hemopure, the Boston Globe reports. The agency is expected to take 10 months to review the application for Hemopure, which is manufactured from cow's blood that has been treated to remove any diseases or pathogens (Krasner, Boston Globe, 10/2). Like red blood cells, Hemopure carries oxygen to body tissues. However, blood substitutes have several advantages: they can be stored at room temperature, can remain potent for years instead of weeks, are less vulnerable to contamination and can be given to patients without the risk of reactions caused by mismatching the blood types of the donor and recipient. But Hemopure and similar substitutes are only considered "partial and temporary" replacements for human blood because the only blood function they can perform is oxygen delivery. In addition, Hemopure may cause some side effects, including slightly increased risk of stomach pain, weakness, hypertension, jaundice and nausea. South Africa approved the product for use in the country last year in order to reduce the risk of HIV transmission through contaminated blood (Kaiser Daily HIV/AIDS Report, 4/10/01). Biopure is also applying for approval to market Hemopure in the European Union, and the company is in "advanced talks" with a manufacturer in Asia to construct a production plant to serve Asian markets, Biopure President and CEO Thomas Moore said (Boston Globe, 10/2).
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