KBroVet® (potassium bromide chewable tablets) Becomes First FDA Fully Approved Pharmaceutical For The Control of Seizures Associated with Idiopathic Epilepsy in Dogs

Once-daily chewable tablet offers longest half-life among available seizure medications

PENSACOLA, Fla., Feb. 12, 2026 /PRNewswire/ -- Pegasus Laboratories, Inc. (Pegasus), is pleased to announce, under its registered trademark PRN^® Pharmacal, that KBroVet^® (potassium bromide chewable tablets) has received full approval from the U.S. Food and Drug Administration (FDA) for the control of seizures associated with idiopathic epilepsy (IE) in dogs.

With this approval, KBroVet becomes the first FDA fully approved pharmaceutical specifically indicated for the control of seizures associated with idiopathic epilepsy in dogs, representing a significant advancement for veterinarians and pet owners managing this chronic neurological condition.

In addition, KBroVet is only the second animal health pharmaceutical, across any condition or disease, to successfully transition from conditional FDA approval to full FDA approval, underscoring the strength of its clinical evidence and long-standing role in veterinary medicine.

"This full FDA approval represents a defining moment not only for KBroVet, but for the many dogs and families affected by idiopathic epilepsy," said Heather Davis, DVM, PhD, DACVS-LA, Director of Clinical Affairs and Veterinary Services at Pegasus. "KBroVet has long been a trusted therapy in clinical practice, and achieving full approval reinforces its credibility, proven effectiveness, safety profile, and compliance as a foundational treatment option for veterinarians."

Approximately 2.1 million dogs in the United States are estimated to be affected by seizures, making it one of the most common neurological disorders in companion animals. The condition requires lifelong management and can significantly impact the quality of life for both dogs and their families.

"As veterinarians, it's important to ask pet owners not just about seizure frequency or type, but what it's truly like to live with the condition," said Fred Wininger, VMD, MS, DACVIM, neurologist at the Animal Neurology Center in St. Louis, Missouri. "Many pause, fight back tears, and describe an exhaustion they never expected. They live in constant anticipation of the next seizure—canceling vacations, monitoring cameras at night, sleeping poorly, and carrying deep guilt over how their pet's illness affects their own lives. That's why seizure therapies that truly add value matter—not just because they treat pets, but because they measurably improve the lives of the people who love them."

Joyce J. Lee, General Manager and Senior Vice President for Pegasus, added, "This milestone for KBroVet reflects decades of scientific commitment, innovation, close collaboration with the veterinary community, and a shared commitment to improving the quality of life for dogs with epilepsy and the people who care for them. Full FDA approval validates that KBroVet plays a critical role in managing seizures associated with idiopathic epilepsy."

KBroVet offers several benefits that make it a valuable option for dogs with idiopathic epilepsy, including those with complex treatment needs:

• Excreted through glomerular filtration, making it an ideal choice for dogs with compromised liver function that may not tolerate anticonvulsants affecting the liver
• Once-daily dosing, which may improve owner compliance compared to therapies requiring multiple daily doses
• Flavored, chewable tablets formulated specifically for dogs
• A half-life of at least 21 days, the longest among available seizure medications, helping minimize fluctuations in drug concentration if a dose is missed (once steady state is reached), and providing added peace of mind for owners
• Available in both 60-count and 180-count bottles, offering flexibility for veterinarians and pet owners when dispensing

While KBroVet^® (potassium bromide chewable tablets) has now received full FDA approval, fully approved product labeling is expected to transition in the marketplace beginning approximately April-May 2026.

KBroVet is approved by the FDA under a New Animal Drug Application (NADA) for use by or on the order of a licensed veterinarian.

For more information, visit https://www.prnpharmacal.com/products/pharmaceuticals/kbrovet-tablets/.

IMPORTANT SAFETY INFORMATION:
KBroVet^® (potassium bromide chewable tablets) is approved by FDA under application number 141-615. See prescribing information for complete details regarding adverse events, warnings, and precautions. Contraindicated in dogs with a history of hypersensitivity to bromide. Not for use in cats. Not for human use. Keep out of reach of children. Contact a physician in case of accidental ingestion by humans. The most commonly reported side effects were increased appetite, weight gain, vomiting/regurgitation, sedation, and ataxia/weakness. Other reported side effects include increased thirst and urination, and lethargy. Reversible neurologic signs (sedation, ataxia, weakness) were generally associated with adjunctive potassium bromide treatment or high serum bromide concentrations. Animals with kidney disease may be predisposed to bromide toxicities. The safe use of KBroVet has not been evaluated in dogs that are intended for breeding, are pregnant or lactating, or less than 6 months of age. Use caution when changing diets, administering chloride-containing IV fluids, and administering concurrent medications. Careful monitoring is important in dogs that have a condition that may cause difficulty maintaining electrolyte balance.

About Pegasus Laboratories, Inc.
Founded in 1986, Pegasus is a pharmaceutical development and manufacturing organization focused on novel products to treat chronic conditions in cats, dogs, and horses and is owned by PBI-Gordon Companies, Inc. Pegasus provides full-service Contract Development and Manufacturing Organization (CDMO) focusing on the development and manufacturing with full turn-key technical services in an FDA-registered facility that is in compliance with current Good Manufacturing Practices (cGMPs). Pegasus also provides a full portfolio of pharmaceuticals, nutritional therapeutics and supplements, parasite control and surgical and wound care under the PRN^® Pharmacal and Sē•Qual™ brands.

SOURCE Pegasus/PRN Pharmacal