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Lilly Arxxant "approvable"

This article was originally published in Pharmaceutical Approvals Monthly

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Executive Summary

Lilly believes it may have to conduct an additional trial of Arxxant (ruboxistaurin) following receipt of an Aug. 17 "approvable" letter. The firm said it plans to meet with FDA to determine whether the agency's request for additional data could be supported by data from an ongoing trial. In July, Lilly announced a co-promotion deal for Arxxant with Alcon (1Pharmaceutical Approvals Monthly August 2006, p. 2)...

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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