Posted by Michael Wonder on 04 Jan 2022
Spero Therapeutics announces FDA acceptance and priority review of new drug application for tebipenem hydrobromide for the treatment of complicated urinary tract infections including pyelonephritis
3 January 2022 - The FDA has set a Prescription Drug User Fee Act target action date of 27 June 2022.
Spero Therapeutics today announced that the U.S. FDA has granted priority review designation and confirmed the acceptance for substantive review of the new drug application seeking approval for tebipenem hydrobromide oral tablets for treatment in adult patients with complicated urinary tract infections, including acute pyelonephritis, caused by susceptible microorganisms.
