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FDA requests additional Arxxant trial

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Lilly "is weighing options for the further development" of its diabetic retinopathy treatment Arxxant (ruboxistaurin) following an FDA request for "an additional, three-year, Phase III clinical trial," the company says Sept. 29. "Lilly believes that such a trial would require up to five years to complete." The news follows a meeting with FDA to discuss options for responding to an "approvable" letter issued in August, at which time Lilly had suggested the possibility of an additional trial (1Pharmaceutical Approvals Monthly September 2006, p. 2)...

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