Lilly Arxxant "approvable"
This article was originally published in Pharmaceutical Approvals Monthly
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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