HYLENEX is a human recombinant formulation of hyaluronidase that has received FDA approval to facilitate the absorption and dispersion of other injected drugs or fluids; for subcutaneous fluid administration; and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents. When injected under the skin or in the muscle, hyaluronidase can degrade the hyaluronan gel, allowing for temporarily enhanced penetration and dispersion of other injected drugs or fluids. We filed a New Drug Application (NDA) in March 2005 and we received FDA approval of our HYLENEX NDA in December 2005.
Baxter announced the commercial launch of HYLENEX recombinant (hyaluronidase human injection) for use in pediatric rehydration in October 2009 at the American College of Emergency Physicians scientific assembly in Boston. In conjunction with the launch, data from the INFUSE-Pediatric rehydration study, “Recombinant Human Hyaluronidase-Enabled Subcutaneous Pediatric Rehydration”, were published in the journal Pediatrics.
