Innoviva Specialty Therapeutics Announces Acceptance Of Zoliflodacin NDA For Review

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

David Altarac, Chief Medical Officer, Innoviva Specialty Therapeutics, said: "We look forward to working closely with the FDA during its review and, if approved, we are committed to expediting the availability of zoliflodacin to patients in the U.S."

The FDA has granted zoliflodacin a Qualified Infectious Disease Product designation. This designation allows it to benefit from FDA Priority Review, and Extended Market Exclusivity.

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