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U.S. FDA approves Hylenex

Published in Medical Letter on the CDC and FDA, January 8th, 2006

Halozyme Therapeutics, Inc., (HTI), a biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, and Baxter Healthcare Corp. announced that the U.S. Food & Drug Administration (FDA) has approved Halozyme's Hylenex recombinant (hyaluronidase human injection) for use as an adjuvant agent to increase the absorption and dispersion of other injected drugs.

Baxter will market and sell Hylenex, a proprietary recombinant human hyaluronidase, in the United States.

"We are thrilled that the FDA has approved our first NDA [new drug application] filing," said Jonathan Lim, MD, Halozyme's chairman and CEO. "This is a...

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