Ista Vitrase sNDA extension
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA's revised action date for Ista's pending sNDA for use of Vitrase (ovine hyaluronidase) as a spreading agent is May 5 following an extension; the original user fee date was Feb. 6 (1Pharmaceutical Approvals Monthly Aug. 1, 2003, In Brief). The extension follows Ista's December amendment containing manufacturing information requested in an April 2003 "approvable" letter. An NDA for vitreous hemorrhage is also pending, with action expected by April 4. Ista recently presented a subset analysis showing greater efficacy in patients with diabetes in the two VH pivotal trials. FDA's Dermatologic & Ophthalmic Drugs Advisory Committee concluded March 17, 2003 that the pivotal data did not demonstrate sufficient efficacy for approval, but agreed that additional subgroup analyses could be used to provide evidence of efficacy...