Manufacturing concerns spike Nabriva’s plans to launch its first antibiotic — for now
In another setback for the beleaguered antibiotics field, Nabriva Therapeutics says the FDA rejected its fosfomycin for complicated urinary tract infections.
Importantly, the biotech says, regulators are not asking for any new clinical or safety data. The complete response letter centers around “issues related to facility inspections and manufacturing deficiencies at one of Nabriva’s contract manufacturers,” according to a brief statement.
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