ISTA Vitrase Clears FDA; Full Launch Awaits New Vial Approval
This article was originally published in The Pink Sheet Daily
Executive Summary
The company will begin providing samples by July; reimbursement issues are expected to be resolved within three to six months. The approval of hyaluronidase removes the product from the drug shortages list.
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Ista Vitrase Launch Set For Early 2005 With Approval Of Smaller Vial Size
Company plans to differentiate the spreading agent based on preservative-free formulation and 200 unit/mL vial size. Inability to fully characterize hyaluronidase results in Vitrase and Amphadase both having new molecular entity status. Ista is in discussions with FDA about “approvable” letter for vitreous hemorrhage indication.
Ista Vitrase Launch Set For Early 2005 With Approval Of Smaller Vial Size
Company plans to differentiate the spreading agent based on preservative-free formulation and 200 unit/mL vial size. Inability to fully characterize hyaluronidase results in Vitrase and Amphadase both having new molecular entity status. Ista is in discussions with FDA about “approvable” letter for vitreous hemorrhage indication.
Vitrase Gains New Molecular Entity Status Due To Lack Of Characterization
Ista’s ovine hyaluronidase is given five years of exclusivity, but Amphastar’s recently approved bovine version Amphadase is grandfathered in. FDA cites “inadequate” data to determine whether Vitrase is the same as previously approved hyaluronidase.