Animal & Veterinary

Approval Withdrawn for Antifreeze Antidote for Dogs

April 7, 2015

The U.S. Food and Drug Administration is announcing that it has withdrawn the approval for Antizol-Vet, also known as fomepizole, 4-methylpyrazole, or 4-MP, at the request of the drug’s sponsor. Originally approved by FDA in 1996, Antizol-Vet is an antidote for ethylene glycol (antifreeze) poisoning in dogs.

Paladin Labs (USA) Inc., the current sponsor of Antizol-Vet, requested that the FDA withdraw the approval because the company has not manufactured or marketed the drug since October 1, 2014. The most recent lot marketed in the U.S. is lot #1319-12A with an expiration date of August 2017.

Orphan Medical, Inc. was the original sponsor of Antizol-Vet. The company transferred ownership of the approved new animal drug application to Paladin Labs in 2009.
 

Contact FDA

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

7519 Standish Place, HFV-1

Rockville, MD 20855

Page Last Updated: 04/07/2015
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