A New Antibiotic is Nearing Approval, but Major Concerns Linger
A panel of U.S. Food and Drug Administration (FDA) experts has recommended that an experimental antibiotic made by Cempra Inc. be approved, but just barely. [1]
The panel voted 7-6 in favor of the drug, saying the effectiveness of the new antibiotic outweighed risks of liver toxicity seen in many studies. The FDA does not have to follow the panel’s recommendation, but it typically does.