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Home » Spero’s Fast-Tracked Antibiotic Drug Candidate for Complicated UTIs Hits Snag
Spero’s Fast-Tracked Antibiotic Drug Candidate for Complicated UTIs Hits Snag
Just ahead of its user fee decision date, Spero Therapeutics was slapped with a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for tebipenem HBr oral tablets for treatment of adult patients with complicated urinary tract infection (cUTI), including pyelonephritis — a type of kidney inflammation with limited oral treatment options.