Faced with a dilemma, the FDA rejects Cempra's antibiotic, demands big safety study
Cempra delivered the FDA’s decision on its antibiotic solithromycin on Thursday morning, a day late and about $185 million short.
Caught on the horns of a dilemma posed by clear evidence of liver toxicity and a growing demand for new antibiotics, the FDA has decided to reject Cempra’s new antibiotic, demanding a large new safety study before reconsidering its position. And the agency flagged a warning that any future label will carefully restrict its use, which will damage its market potential.
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