Innoviva Specialty Therapeutics announces FDA accepts NDA for zoliflodacin

Innoviva (INVA) Specialty Therapeutics, a subsidiary of Innoviva, in collaboration with the Global Antibiotic Research & Development Partnership, announced that the U.S. FDA has accepted its New Drug Application for zoliflodacin, the investigational first-in-class, single dose, spiropyrimidinetrione oral antibiotic for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older. If approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades.