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ISTA Pharmaceuticals, Inc.

Supplemental NDA submitted for Vitrase for use as a spreading agent

Published in Lab Business Week, August 29th, 2004

ISTA Pharmaceuticals, Inc., (ISTA) has submitted a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) seeking approval for a single-use, 150 USP Units/mL vial of Vitrase (hyaluronidase for injection; lyophilized, ovine) for use as a spreading agent.

The company believes that the new vial size would be optimal for spreading agent use.

Vicente Anido, Jr., PhD, president and chief executive officer of ISTA stated, "We believe that a smaller vial size that is already reconstituted will greatly enhance the convenience of using Vitrase as a spreading agent by ophthalmologists and increase their familiarity with the...

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