Jaguar Health Inc. (NASDAQ: JAGX), a San Francisco-based biopharmaceutical company, has received fee waivers from the U.S. Food and Drug Administration (FDA) for two of its products, covering the 2027 fiscal year. The waivers include a Prescription Drug User Fee Act (PDUFA) fee waiver for Mytesi (crofelemer delayed-release tablets) and a separate waiver from the FDA’s Center for Veterinary Medicine for Canalevia-CA1.
Mytesi is an FDA-approved drug for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS who are on antiretroviral therapy. Commercialization of Mytesi in the U.S. is handled by Future Pak, LLC. The active ingredient, crofelemer, is derived from the red bark sap of the Croton lechleri tree, sourced from the Amazon rainforest.
Canalevia-CA1 is conditionally approved for the treatment of chemotherapy-induced diarrhea in dogs. Both drugs are part of Jaguar Health’s broader portfolio, with Napo Pharmaceuticals described as a family-owned subsidiary contributing to its development and commercialization efforts.
The PDUFA fee waiver ensures continued regulatory support for Mytesi, while the veterinary medicine waiver extends coverage for Canalevia-CA1, reflecting the FDA’s commitment to advancing both human and animal health treatments.
