Posted by Michael Wonder on 13 Jun 2025
FDA grants priority review for zoliflodacin new drug application for the treatment of uncomplicated gonorrhoea
12 June 2025 - Innoviva Specialty Therapeutics today announced that the US FDA has granted priority review for the new drug application for zoliflodacin, an investigational first in class, single dose, spiropyrimidinetrione oral antibiotic for the treatment of uncomplicated gonorrhoea in adults and paediatric patients 12 years and older.
The FDA assigned a target action date of 15 December 2025 under the Prescription Drug User Fee Act.
