Vitrase Gains New Molecular Entity Status Due To Lack Of Characterization
This article was originally published in The Pink Sheet Daily
Executive Summary
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.