The U.S. Food and Drug Administration acknowledged Nabriva Therapeutics PLC's resubmission of an application for injectable medicine Contepo to treat complicated urinary tract infections after a prior rejection.
Dublin-based Nabriva is seeking approval of Contepo to treat complicated urinary tract infections including acute pyelonephritis, a type of urinary tract infection that usually begins in the bladder and travels to one or both kidneys.
An initial application for Contepo was previously rejected by the FDA due to issues regarding facility inspections and manufacturing deficiencies. No new clinical data was requested by the regulator.
The regulator will make a decision on the application by June 19.
Contepo is an injection-administered antibiotic that works by improving the absorption and effects of fosfomycin, which was originally approved in Europe over 45 years ago to treat a variety of infections.