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Amphastar's Spreading Agent Amphadase Clears FDA

This article was originally published in The Pink Sheet Daily

Executive Summary

Approval of a 150 unit/mL version could give Amphadase an advantage over Ista's hyaluronidase product Vitrase, which cleared FDA in May but is awaiting approval of a smaller, single-use vial. The enzyme drug has been in shortage since Wyeth discontinued Wydase in 2002.

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FDA “Unable” To Act On Hylenex By User Fee Deadline

Approval of Halozyme Therapeutics’ hyaluronidase product could be bogged down by ongoing legal arguments over Ista’s Vitrase exclusivity.

FDA “Unable” To Act On Hylenex By User Fee Deadline

Approval of Halozyme Therapeutics’ hyaluronidase product could be bogged down by ongoing legal arguments over Ista’s Vitrase exclusivity.

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.

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