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Vitrase review delayed by 3 months

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IRVINE, Calif. — The Food and Drug Administration has delayed completing its review on Vitrase for an additional 90 days, to May 5, 2004, the drug’s marketer announced earlier this month.

Ista Pharmaceuticals noted in a press release that the FDA sent the company written notification of its intentions, and that the extension will allow “full review of the submission.”

Vitrase, a proprietary formulation of ovine hyaluronidase, is in development for the treatment of vitreous hemorrhage. The company filed a second marketing application last summer in response to an FDA request for additional information.