Univax Biologics Inc. announced Monday that FDA's BloodProducts Advisory Committee will consider WinRho SD onMarch 24. Univax filed a product license application (PLA) forWinRho SD last June. The Rockville, Md., company licensedWinRho SD from Rh Pharmaceuticals of Winnipeg, Manitoba, inNovember 1992. Univax is seeking an indication for severeblood disorders including idiopathic thrombocytopenic purpura(ITP) and prevention of Rh isoimmunization in newborns.
The blood product, a hyperimmune intravenous humanpolyclonal antibody, received orphan designation lastNovember for the treatment of ITP. The product is currentlysold in Canada for the prevention of Rh isoimmunization.
Univax's stock (NASDAQ:UNVX) closed at $7.88 per share onMonday, down 13 cents. -- Karl Thiel
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