Jaguar Health Receives Fee Waivers from FDA

Jaguar Health said the U.S. Food and Drug Administration has granted a Prescription Drug User Fee Act (PDUFA) fee waiver request for its family company Napo Pharmaceuticals for Mytesi (crofelemer delayed-release tablets) for the 2027 fiscal year. The company says Mytesi is FDA-approved for symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy, and is currently commercialized in the U.S. by Future Pak, LLC. Jaguar also received an FDA Center for Veterinary Medicine fee waiver for 2027 for Canalevia-CA1, its conditionally approved veterinary prescription for chemotherapy-induced diarrhea in dogs, also commercialized by Future Pak.