Hylenex Approval History
FDA Approved: Yes (First approved December 2, 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, 2005||Hylenex Halozyme Therapeutics/Baxter Healthcare Corporation - Treatment for Adjuvant Agent to Enhance Drug Delivery|
|May 26, 2005||Halozyme Therapeutics Announces FDA Acceptance of Hylenex NDA|
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