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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

DateArticle
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

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