FDA Grants First Conditional Approval Under Expanded Authority to Control Seizures in Dogs with Idiopathic Epilepsy
January 14, 2021 Today, the U.S. Food and Drug Administration granted the first conditional approval under its expanded authority to KBroVet-CA1 (potassium bromide chewable tablets) to control seizures in dogs with idiopathic epilepsy. Idiopathic epilepsy is a type of seizure disorder without a known cause. KBroVet-CA1 works by stabilizing neurons in the central nervous system to reduce the likelihood of having a seizure. 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 ...
Source: fda.gov