ZLB Rhophylac clears FDA
Executive Summary
ZLB Bioplasma will make its IGIV product Rhophylac available in the U.S. in March, the company says. FDA approved Rhophylac for the prevention of hemolytic disease of the fetus and newborn Feb. 17. Rhophylac is the first U.S.-approved liquid Rh immune globulin product that can be administered either intravenously or intramuscularly, ZLB said. Rhophylac labeling does not include a precaution about an association between IGIV products and thrombotic events as requested by FDA for all IGIV products (1"The Pink Sheet" Jan. 5, 2004, p. 18)...
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