ACCESS Newswire·Sep 22, 2026, 9:05 AM ET

Jaguar Health Receives Fee Waivers from FDA

Jaguar Health family company Napo Pharmaceuticals received an FDA waiver of the Prescription Drug User Fee Act (PDUFA) fee for Mytesi for the 2027 fiscal year.
Jaguar Health also received an FDA Center for Veterinary Medicine waiver of the fee for Canalevia-CA1 for the 2027 fiscal year.
Mytesi is an FDA-approved prescription drug for the symptomatic relief of noninfectious diarrhea in adult HIV/AIDS patients on antiretroviral therapy, commercialized in the U.S. by Future Pak, LLC.
Canalevia-CA1 is a conditionally approved prescription drug for chemotherapy-induced diarrhea in dogs, also commercialized in the U.S. by Future Pak, LLC.
Jaguar Health remains focused on its global development program for crofelemer powder for oral solution targeting microvillus inclusion disease (MVID) & short bowel syndrome (SBS).
The company targets a New Drug Application (NDA) filing for MVID in mid-2027.
Jaguar's family companies include Napo Pharmaceuticals, Napo Therapeutics S.p.A., & Magdalena Biosciences, which focus on plant-derived medicines for gastrointestinal disorders & mental health indications.
Mytesi is derived from the red bark sap of the Croton lechleri tree, with a sustainable harvesting program established by Napo.
Forward-looking statements in the release regarding the 2027 NDA filing are based on current expectations & subject to risks & uncertainties.