Baxter International, Inc. Submits Amended BLA To U.S. FDA for Hyqvia For Primary Immunodeficiency
Published: Dec 02, 2013
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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