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Baxter International, Inc. (BAX) Provides U.S. Regulatory Update On Hyqvia, Its Investigational Subcutaneous Treatment For Primary Immunodeficiency


5/21/2014 9:10:41 AM

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DEERFIELD, Ill. & SAN DIEGO--(BUSINESS WIRE)--Baxter International Inc. (NYSE:BAX) and Halozyme Therapeutics, Inc., (NASDAQ:HALO) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the Biologics License Application (BLA) for HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase], the company’s investigational subcutaneous treatment for patients with primary immunodeficiency (PI).

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