FDA Completes Risk Review of Freeze-Dried Plasma for Treatment of Hypovolemia and Control of Hemorrhage in Dogs

December 18, 2025

The U.S. Food and Drug Administration has completed a risk review of Mantel’s Canine Freeze-Dried Plasma (pooled allogeneic canine freeze-dried plasma) for the treatment of hypovolemia and control of hemorrhage in dogs.

FDA evaluated Mantel’s Canine Freeze-Dried Plasma (cFDP) product characteristics, manufacturing, donor eligibility, the available current scientific literature on freeze-dried plasma, and the studies conducted using Mantel’s cFDP to determine if risks are appropriately mitigated. FDA also evaluated these factors in comparison to other plasma products (e.g., fresh frozen plasma).

Based on the data and information received, FDA concluded that the developer of Mantel’s cFDP properly identified and appropriately mitigated the potential risks associated with the product, the product has similar properties to other plasma products, and FDA has no additional safety concerns.

Although Mantel’s cFDP is not approved, conditionally approved, or index listed, because FDA has determined the risks associated with this product are appropriately mitigated, at this time FDA does not intend to object to marketing of the product.

This cFDP product is shelf stable for at least one year and can be reconstituted for intravenous use in acute medical emergencies in dogs when whole blood products may not be available, such as with trauma cases with military working dogs and dogs in remote locations. Typically, fresh blood and plasma products require storage in refrigerators or freezers, have short shelf lives, and may require thawing before use.

Mantel’s cFDP is available by prescription only through a licensed veterinarian and specialized veterinary medical expertise is necessary for the safe use of the product. Each Mantel’s cFDP kit includes 20 grams of Mantel’s cFDP in a 250 mL single-use bag, 250 mL sterile water for injection to reconstitute the cFDP, and a set to administer the product to a dog intravenously.

Mantel’s cFDP was developed by Mantel Technologies of Fort Collins, Colorado.

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