Jaguar Health Receives Fee Waivers from FDA

Jaguar Health, Inc., through its subsidiary Napo Pharmaceuticals, has announced that the FDA has granted a waiver for the fee under the Prescription Drug User Fee Act (PDUFA) for fiscal year 2027. This waiver applies to Mytesi, a prescription drug for noninfectious diarrhea in adults with HIV/AIDS. Mytesi is produced for the U.S. market by Future Pak, LLC.

The Center for Veterinary Medicine has similarly granted a fee waiver for Canalevia-CA1, targeting chemotherapy-induced diarrhea in dogs, also marketed by Future Pak, LLC. These waivers alleviate financial burdens for Jaguar Health, supporting its drug development and commercialization efforts.