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Baxter re submits HyQvia at FDA for Immunodeficiency

Read time: 1 mins
Last updated:3rd Dec 2013
Published:3rd Dec 2013
Source: Pharmawand

Baxter International Inc. and Halozyme Therapeutics, Inc. announced that Baxter has completed submission of an amended biologics license application (BLA) to the 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).

HyQvia is a combination of human immune globulin (IG) and recombinant human hyaluronidase. Baxter and Halozyme submitted additional preclinical data that was requested from the FDA in 2012, and expect a six-month review period.

HyQvia was approved and launched in a number of European countries in the second half of 2013.

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