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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.

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