FDA Approves Second Insulin Drug for Diabetic Dogs

The U.S. Food and Drug Administration’s Center for Veterinary Medicine (FDA-CVM) announced today that it has approved the drug ProZinc (protamine zinc recombinant human insulin) for managing diabetes mellitus in dogs. This product has not been evaluated for use in people.

ProZinc is already approved for use in cats, and veterinarians have used the products with dogs prior to the approval under “off-label” use. With this approval, the FDA has determined that ProZinc is safe and effective in reducing high blood sugar and associated clinical signs in dogs with diabetes mellitus. Dogs with diabetes mellitus require careful veterinary management to reach and maintain the appropriate level of insulin replacement.

ProZinc must be prescribed by a licensed veterinarian because a trained professional is needed to correctly diagnose and manage diabetes mellitus and determine if ProZinc is an appropriate treatment. The FDA recognizes the veterinary medical challenges associated with managing diabetic dogs and defers to the veterinarian’s clinical judgement on which FDA-approved insulin drug product is appropriate for use in their canine patients.

The FDA strongly encourages use of an FDA-approved animal insulin drug product for newly-diagnosed dogs, or when transitioning dogs from one product to another. In addition to ProZinc, Vetsulin (porcine insulin zinc suspension) is also approved for use in dogs. ProZinc is available in 10 mL multi-dose vials at a concentration of 40 international units/mL and is manufactured by Boehringer Ingelheim Animal Health USA Inc.

Click here to read the full FDA announcement, plus the FDA’s letter to veterinarians regarding ProZinc and the FOIA Summary of the ProZinc drug application.