Vitrase Approval History
FDA Approved: Yes (First approved May 5, 2004)
Brand name: Vitrase
Generic name: hyaluronidase
Dosage form: for Injection
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.
Development History and FDA Approval Process for Vitrase
|May 5, 2004||Vitrase ISTA Pharmaceuticals, Inc. - Treatment for Spreading Agent|
|Feb 6, 2004||Review of ISTA Pharmaceuticals' New Drug Application for Vitrase for Use as a Spreading Agent Extended 90 Days by FDA|
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