Vitrase Gains New Molecular Entity Status Due To Lack Of Characterization
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
NME or not NME? FDA’s question is whether Vitrase is the same as previously approved hyaluronidase. Agency concludes activity shown by USP test supports approval for 505(b)(2) NDA; lack of characterization qualifies Ista’s ovine hyaluronidase for five years of exclusivity