Published in Medical Letter on the CDC and FDA, May 31st, 2006
The purpose of the meeting was to discuss the proposed new drug application (NDA) submission for AzaSite, the company's ocular anti-infective product. InSite recently announced the successful completion of the second of two required phase III clinical trials to evaluate the safety and efficacy of AzaSite. In this study, patients treated with AzaSite had a significantly higher clinical resolution rate, the trial's primary efficacy end point, and a significantly higher...
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