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Animal & Veterinary

FDA Publishes Target Animal Safety Data to Support Drug Applications for Potassium Bromide to Control Seizures in Dogs

September 30, 2014

The U.S. Food and Drug Administration is announcing the availability of Public Master File (PMF) 6074 containing target animal safety data for potassium bromide (KBr) for the control of seizures associated with idiopathic epilepsy in dogs.

The purpose of a PMF is to provide a repository for publicly available studies or other non-proprietary information, which can be used or referenced by pharmaceutical sponsors (at no cost) to support a New Animal Drug Application (NADA) toward the approval of this drug. Sponsors that wish to seek a drug approval would need to also supply additional effectiveness, manufacturing, environmental and other required information, as well as labeling, to submit a complete NADA. There are not currently any FDA-approved potassium bromide products for use in dogs.

For questions or further information, please contact: Elizabeth Luddy, Center for Veterinary Medicine, FDA, 7500 Standish Pl., Rockville, MD 20855, 240–402-0627, elizabeth.luddy@fda.hhs.gov.

Contact FDA

240-402-7002
240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

7519 Standish Place, HFV-1

Rockville, MD 20855

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