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Vitrase FDA 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 timeline for Vitrase

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

Further information

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