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 with caution, outlining several steps to address the possible liver...
Advisory Committee Votes
- 7-6 that Solithera’s efficacy outweighs its risks, including hepatotoxicity
- 13-0 that Solithera provided substantial evidence of efficacy
- 12-1 that Cempra failed to adequately characterize the risk of...
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