Jaguar health announces fda agrees with clinical trial protocol for full approval of canalevia-ca1 for treatment of chemotherapy-induced diarrhea (cid) in dogs

Canalevia®-ca1 is currently fda conditionally approved for treatment of cid in dogs and is the first and only treatment for cid in dogs to receive any type of approval from fda by prescription only, canalevia-ca1 is a canine-specific formulation of crofelemer, jaguar's novel, oral plant-based product sustainably harvested from the croton lechleri tree san francisco, ca / accesswire / february 15, 2024 / jaguar health, inc. (nasdaq:jagx), under its jaguar animal health tradename for the veterinary market, today announced that it has reached agreement with the u.s. food and drug administration (fda) on the design and conduct of a clinical field study of canalevia-ca1 (crofelemer delayed-release tablets), the company's fda conditionally approved prescription drug for the treatment of chemotherapy-induced diarrhea (cid) in dogs, for full approval of the product. canalevia-ca1 received conditional approval in december 2021 from the fda for the treatment of cid in dogs and is available from multiple leading veterinary distributors in the u.s. conditional approval allows for commercialization of the product while jaguar continues to collect the substantial evidence of effectiveness required for full approval.
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