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Cempra To Defend CABP Antibiotic's Safety At US FDA Advisory Panel

Executive Summary

Solithera's efficacy profile appears strong, but FDA has safety concerns, particularly its structural similarities to the controversial Ketek.

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Limited population approval pathway in 21st Century Cures law may not help Cempra overcome US agency's request for new 9,000-patient safety study of the macrolide antibiotic.

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FDA advisory committee votes 7-6 that the strong efficacy profile of Solithera (solithromycin) outweighs its unknown safety risks; panels agreed that more data was needed, but were split on whether it was needed pre- or post-approval.

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