Skip to Content

Hylenex Approval History

  • FDA approved: Yes (First approved December 2nd, 2005)
  • Brand name: Hylenex
  • Generic name: hyaluronidase
  • Dosage form: Injection
  • Previous name: Enhanze SC
  • Company: Halozyme Therapeutics/Baxter Healthcare Corporation
  • Treatment for: Adjuvant Agent to Enhance Drug Delivery

Hylenex recombinant is a purified preparation of the enzyme recombinant human hyaluronidase, indicated for use as an adjuvant agent to increase the absorption and dispersion of other injected drugs, for hypodermoclysis, and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents.

Development History and FDA Approval Process for Hylenex

Dec  2, 2005Approval Hylenex Halozyme Therapeutics/Baxter Healthcare Corporation - Treatment for Adjuvant Agent to Enhance Drug Delivery
May 26, 2005Halozyme Therapeutics Announces FDA Acceptance of Hylenex NDA

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.