What happened (Thailand’s FDA approval)
Thailand’s Food and Drug Administration (FDA) approved Nuzolvence (zoli(f)odacin) for uncomplicated urogenital gonorrhoea. The approved treatment is described as a first-in-class oral antibiotic for this indication.
Regulatory pathway and the actors involved
The approval followed a priority review submission led by Dr. Reddy’s Laboratories, with support from the GARDP (Global Antibiotic Research and Development Partnership) Foundation. Priority review indicates a faster regulator assessment track when a medicine is considered important for urgent or serious clinical needs.
Background and earlier position (U.S. approval first)
Thailand is reported to be the second country to approve the medicine’s new chemical entity after the U.S. FDA approval, issued about six months earlier. A new chemical entity refers to a drug whose active ingredient is not previously approved by that regulator as a marketed medicine.
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