FDA Warns Baxter On Hemophilia Drug Promotion

Law360, New York (July 31, 2008, 12:00 AM EDT) -- The U.S. Food and Drug Administration has warned Baxter Healthcare Corp. over a promotion of one of its hemophilia drugs that the agency says overstates the coagulant's safety and efficacy.

The company's "clinical thank you e-mail" misbrands FEIBA VH — a drug containing freeze-dried sterile human plasma that helps to limit spontaneous or surgical bleeding in patents with hemophilia — and violates the U.S. Food, Drug and Cosmetic Act, according to a letter posted to the agency's Web site Wednesday.

"By promoting misleading safety and efficacy...
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