Canalevia-CA1 (Crofelemer delayed-release tablets) is an antidiarrheal, enteric-coated drug product indicated for the treatment of chemotherapy-induced diarrhea in dogs. Crofelemer inhibits the hypersecretion of Cl- in diarrhea and normalizes the fluid influx into the GI tract. The mechanism of action in the dog has not been fully characterized. A reasonable expectation of effectiveness may be demonstrated based on evidence from published literature. Canalevia-CA1 is conditionally approved pending a full demonstration of effectiveness. Additional information for Conditional Approvals can be found at www.fda.gov/animalca.