Cempra Inc.'s antibiotic Solithera (solithromycin) has landed a complete response letter from the US FDA for community acquired bacterial pneumonia (CABP), and even the recently enacted 21st Century Cures legislation's limited population approval pathway may not be enough to save it from a large, pre-approval safety study.
In declining to approve Solithera, FDA said the company had not adequately characterized the macrolide antibiotic's safety profile – specifically regarding the risk of hepatotoxicity – with its clinical safety database of 920
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