Vitrase Approval History

  • FDA approved: Yes (First approved May 5th, 2004)
  • Brand name: Vitrase
  • Generic name: hyaluronidase
  • Company: ISTA Pharmaceuticals, Inc.
  • Treatment for: Hypodermoclysis, Subcutaneous Urography

Vitrase is a preparation of purified ovine testicular hyaluronidase indicated as an adjuvant 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.

FDA Approval History for Vitrase

DateArticle
May  5, 2004Approval Vitrase ISTA Pharmaceuticals, Inc. - Treatment for Spreading Agent
Feb  6, 2004Review of ISTA Pharmaceuticals' New Drug Application for Vitrase for Use as a Spreading Agent Extended 90 Days by FDA

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.

Hide
(web4)