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Baxter International, Inc. (BAX) Submits Amended BLA To U.S. FDA for Hyqvia For Primary Immunodeficiency


12/2/2013 10:07:30 AM

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DEERFIELD, Ill. & SAN DIEGO--(BUSINESS WIRE)--Baxter International Inc. (NYSE:BAX) and Halozyme Therapeutics, Inc. (NASDAQ:HALO) announced today that Baxter has completed submission of an amended biologics license application (BLA) to the United States Food and Drug Administration (FDA) to re-initiate the review process for approval of HyQvia [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] facilitated subcutaneous infusion for the treatment of adult patients with primary immunodeficiency (PI).

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