FDA Grants Full Approval for Canine Idiopathic Epilepsy Medication

The FDA has granted full approval to potassium bromide chewable tablets (KBroVet), developed by Pegasus Laboratories, Inc., for the management of seizures in dogs with idiopathic epilepsy. The prescription-only medication is administered daily and requires Veterinary oversight to ensure proper diagnosis, monitoring, and safe use. Pet owners are advised to closely monitor dogs for signs of bromide intoxication and to avoid sudden dietary changes, which can affect seizure control or safety.

KBroVet initially received conditional approval in January 2021 under the FDA’s expanded conditional approval pathway, created to address serious or life-threatening conditions lacking approved treatments. Idiopathic epilepsy affects about 5% of dogs and can be life threatening. After four annual renewals and submission of required effectiveness data, the drug achieved full approval. Idiopathic epilepsy typically begins between 6 months and 6 years of age and is more common in certain purebred dogs and in males.