September 6, 2023
Today, the U.S. Food and Drug Administration conditionally approved Fidoquel-CA1 (phenobarbital tablets) for the control of seizures associated with idiopathic epilepsy in dogs. Idiopathic epilepsy is a type of seizure disorder without a known cause and is a serious or life-threatening condition that affects approximately 5% of dogs.
Unapproved phenobarbital tablets from the human drug marketplace have historically been used in veterinary medicine to help control seizures in dogs. Fidoquel-CA1 are the only phenobarbital tablets that have received the agency’s conditional approval for safety, quality manufacturing and reasonable expectation of effectiveness.
Fidoquel-CA1 is the second drug to receive FDA approval for the control of seizures in dogs with idiopathic epilepsy. The agency conditionally approved KBro Vet-CA1 (potassium bromide) in 2021.
Conditional approval allows an animal drug sponsor to legally market its product after demonstrating that the drug is safe and manufactured in accordance with full approval standards, and that there is a reasonable expectation of effectiveness for use.
The initial conditional approval is valid for one year with the potential for four annual renewals. During this time, the animal drug sponsor must demonstrate that it is actively working toward collecting the remaining effectiveness data needed to achieve full approval. The animal drug sponsor must attain full approval within five years after receiving conditional approval, or it will no longer be in effect.
Congress granted the FDA a limited expansion of the conditional approval pathway for certain new animal drugs under the 2018 reauthorization of the FDA’s Animal Drug User Fee Act (ADUFA) program. Fidoquel-CA1 qualified for conditional approval because it is intended to address a serious or life-threatening disease or condition and demonstrating effectiveness would require complex or particularly difficult studies, due to the unpredictability of idiopathic epileptic seizures.
Prior to this expansion, the FDA’s conditional approval of new animal drugs had been limited to drugs for use in minor species (those other than horses, dogs, cats, cattle, pigs, turkeys, and chickens) or for diseases in the major species that occur infrequently or in limited geographic areas and in only a small number of animals annually.
Conditional approval of Fidoquel-CA1 was granted to Genus Lifesciences Inc., of Allentown, Penn.
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Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.