2021

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Jaguar Animal Health

Dec 20, 2021

Jaguar Health Shares Comments from FDA’s December 21 Press Release About Conditional Approval of...

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Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552.

CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal Law to use this product other than as directed in the labeling.

IMPORTANT SAFETY INFORMATION

For oral use in dogs only. Not for use in humans. Keep Canalevia®-CA1 (crofelemer delayed-release tablets) in a secure location out of reach of children and other animals. Consult a physician in case of accidental ingestion by humans. Do not use in dogs that have a known hypersensitivity to crofelemer. Prior to using Canalevia-CA1, rule out infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment of chemotherapy-induced diarrhea in dogs. The most common adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting.

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal law to use this product other than as directed in the labeling. Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552.

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