FDA Policy/General

Canine Idiopathic Epilepsy Drug Approved

Using expanded authority granted to it by Congress in the 2018 reauthorization of the Animal Drug User Fee Act, FDA has given the first conditional approval to Pegasus Laboratories’ KBroVet-CA1 (potassium bromide chewable tablet) to control seizures in dogs with idiopathic epilepsy. An agency news release says the drug works by stabilizing neurons in the central nervous system to reduce the likelihood of having a seizure.

The conditional approval pathway allows an animal drug sponsor to legally market its product after demonstrating that the drug is safe and manufactured following full approval standards and that there is a reasonable expectation of effectiveness for use.

The agency says KBroVet-CA1 meets the criteria of conditional approval under the expanded authorization as there currently is no animal drug approved and marketed in the U.S. to treat idiopathic epilepsy in dogs.

The initial conditional approval is valid for one year, with the potential for four annual renewals. During this time the sponsor must demonstrate that it is actively working toward collecting the remaining effectiveness data needed to achieve full approval. The sponsor must attain full approval within five years after receiving conditional approval, or the conditional approval will no longer be in effect.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome