FDA grants Jaguar Health fee waivers for two drugs in fiscal 2027

Jaguar Health, Inc. (NASDAQ: JAGX) announced that the U.S. Food and Drug Administration has granted fee waivers under the Prescription Drug User Fee Act for two of its drugs for the 2027 fiscal year, according to a company press release.

Napo Pharmaceuticals, a Jaguar family company, received a waiver of the PDUFA fee for Mytesi (crofelemer delayed-release tablets). Mytesi is an FDA-approved prescription drug for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy. The drug is currently commercialized in the U.S. by Future Pak, LLC.

Jaguar also received a separate waiver from the FDA's Center for Veterinary Medicine for Canalevia-CA1, the company's conditionally approved prescription drug for the treatment of chemotherapy-induced diarrhea in dogs. Canalevia-CA1 is also commercialized in the U.S. by Future Pak, LLC.

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