The FDA cleared Achaogen’s antibiotic Zemdri (plazomicin) with a black-box warning.
The drug won FDA approval with an indication for treatment of complicated urinary tract infections in adults. The boxed warning will specify its risks for hearing loss, kidney damage and neuromuscular blockade, as well as harm to developing fetuses.
The agency did not approve the drug for an indication for treatment of bloodstream infections, citing lack of efficacy data. The drugmaker hopes to meet with FDA officials to negotiate a second try for this indication.