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May 21, 2014
09:01 EDTHALO, BAXBaxter provides U.S. regulatory update on HyQvia
Baxter International (BAX) and Halozyme Therapeutics (HALO) announced that the U.S. Food and Drug Administration has extended the PDUFA date for its review of the Biologics License Application for HYQVIA, the company’s investigational subcutaneous treatment for patients with primary immunodeficiency. The FDA is requiring additional time to review supplemental data that Baxter provided as part of the ongoing BLA process for HyQvia approval. The PDUFA date has been extended by three months, which is the standard extension period. As part of the FDA’s extended review of the HyQvia BLA amendment, Baxter now expects to participate in a Blood Products Advisory Committee meeting, which the agency has scheduled for July 31.HyQvia was approved by the European Commission for EU member states in 2013 and is available in several European countries, including Germany, Netherlands, Sweden, Norway, Denmark, Ireland and Italy.
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