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Advisory Committee Recommendations Could Limit Use Of Solithera

 
• By Michael Cipriano

Panelists recommended stringent labeling for Cempra's proposed antibiotic for community-acquired bacterial pneumonia, which could ultimately limit utilization of the drug over concerns about possible liver damage.

If FDA ultimately approves Cempra Inc.'s community-acquired bacterial pneumonia antibiotic Solithera (solithromycin), the agency’s Antimicrobial Drugs Advisory Committee has recommended stringent labeling and risk management that could limit sales of the drug.

Although a razor-thin majority of panelists at the Nov. 4 review supported approval, those who gave their backing did so...

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