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CABP Trial Guidance Snarls Advanced Life Sciences Cethromycin: FDA Panel Votes Against Drug

This article was originally published in The Pink Sheet Daily

Executive Summary

Company says it remains committed to developing Restanza for community acquired bacterial pneumonia.

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FDA calls for another trial of Advanced Life Science's cethromycin

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

FDA calls for another trial of Advanced Life Science's cethromycin

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

Advanced Life Sciences’ Cethromycin Faces Anti-Infectives Panel With Solid Data

Firm is first of several near-term NDAs for community acquired pneumonia to come before FDA this year amid changing regulatory standards for anti-infective development.

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