FDA calls for another trial of Advanced Life Science's cethromycin
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Data for Advanced Life Science's Restanza (cethromycin) falls officially short of FDA's new non-inferiority standards for community acquired pneumonia drugs: the firm received a "complete response" letter July 31 for the NDA, with FDA indicating that additional efficacy data are needed prior to approval. ALS said it believes a trial in a more severe CAP population will be necessary. FDA convened an advisory committee in June to review the application in light of the new non-inferiority trial criteria, and though the panel voted that Restanza was safe, it agreed with FDA that its efficacy fell short ("The Pink Sheet" DAILY, June 2, 2009). ALS said it hopes to design the additional study under a Special Protocol Assessment with FDA
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