FDA Grants Full Approval of a Drug to Control Seizures in Dogs with Idiopathic Epilepsy
January 21, 2026
The U.S. Food and Drug Administration has granted full approval to KBroVet (potassium bromide chewable tablets) for the control of seizures in dogs with idiopathic epilepsy, a type of seizure disorder without a known cause.
KBroVet is orally administered daily for the control of seizures associated with idiopathic epilepsy in dogs. It is available only by prescription due to the professional veterinary expertise required to diagnose idiopathic epilepsy and to monitor safe use of the product, including treatment of any adverse reactions.
It is important for owners of dogs with idiopathic epilepsy to work closely with their veterinarians to monitor clinical signs to help avoid bromide intoxication, which occurs when high levels of bromide overwhelm the nervous system. It is also important to avoid abrupt diet changes in dogs receiving potassium bromide because it could either compromise seizure control or raise safety concerns. Signs of severe bromide intoxication can include depression, behavioral changes, poor coordination, weakness or partial loss of voluntary movement in hind limbs, dilated pupils, stupor and coma.
In January 2021, the FDA conditionally approved KBroVet, making it the first drug conditionally approved under the FDA’s expanded conditional approval authority for certain new animal drugs not intended for a minor use or minor species (MUMS) (“expanded conditional approval”).
Expanded conditional approval allows for conditional approval of treatment options that are intended to address a serious or life-threatening disease or condition, or an unmet health need, but for which demonstrating effectiveness would require complex or particularly difficult studies. KBroVet met the qualifying criteria because there were no approved and marketed drugs for idiopathic epilepsy in dogs in the U.S., and this serious and sometimes life-threatening condition affects approximately 5% of the canine population.
A conditional approval is valid for one year with the potential for up to four annual renewals. During this time, the animal drug sponsor must demonstrate active progress toward proving substantial evidence of effectiveness for full approval. The animal drug sponsor has five years to obtain full approval after receiving conditional approval, or the animal drug can no longer be marketed.
After four annual renewals, the drug sponsor, Pegasus Laboratories, Inc. of Pensacola, Florida, generated the necessary effectiveness data to support a full approval.