In Brief: Univax' WinRho SD
Univax' WinRho SD: Rho(D) immune globulin intravenous approved March 24 for the treatment of idiopathic thrombocytopenic purpura, and for the suppression of Rh isoimmunization in Rho(D) negative pregnant women and Rho(D) negative women being transfused with Rho(D) positive blood. The RhIVIG orphan product requires less volume and less time for administration than other immune globulins used to treat the conditions. WinRho SD, which uses a solvent detergent step to inactivate viral particles, was recommended for approval by an FDA advisory committee in March 1994 ("The Pink Sheet" March 28, 1994, T&G-9). The WinRho SD PLA has been pending since June 1993. Winnipeg, Canada-based Rh Pharmaceuticals will manufacture the product for Univax...
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