FDA Grants Priority Review For Innoviva's Zoliflodacin For Treatment Of Uncomplicated Gonorrhea

(RTTNews) - Innoviva Specialty Therapeutics, Inc., a unit of Innoviva, Inc. (INVA), in partnership with the Global Antibiotic Research & Development Partnership (GARDP), Thursday said that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for zoliflodacin for the treatment of uncomplicated gonorrhea, a sexually transmitted infection, in individuals 12 years of age and older.

The Prescription Drug User-Fee Act (PDUFA) target action date or a decision from the regulator is expected on December 15, 2025.

The company expects that the FDA will notify it about the FDA's decision to conduct an Advisory Committee Meeting in the Day 74 letter.