The US Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) announced the voluntary withdrawal of the combination medicated feed containing Safe-Guard (fenbendazole) and Lincomix (lincomycin), under the New Animal Drug Application (NADA) 140-954, for use in swine.
NADA 140-954 provided for the combination of these two medications to be mixed together in swine feed. They were used for the removal of certain internal parasites and for the treatment and control of swine dysentery, and for reduction in the severity of swine mycoplasmal pneumonia.
However, the sponsor, Merck Animal Health, requested that CVM withdraw the application, and that move means that swine feed that contains both drugs can no longer be manufactured.
Veterinary feed directive drug
Lincomycin is a veterinary feed directive (VFD) drug, so any use of lincomycin, alone or in a combination, requires a VFD order from a veterinarian. “Because this application has been withdrawn, mixing these two drugs in combination is no longer permitted, and VFD orders authorizing their use in combination may no longer be issued,” remarked the CVM.
While veterinarians can no longer issue a VFD for a Type C medicated feed containing both medications, the FDA agency said both drugs remain available for use individually according to their approved labels, as fenbendazole and lincomycin are marketed as separate Type A medicated articles
“Pork producers who manufacture their own medicated feeds should also be aware of this action. Specifically, that although these two medicated articles can continue to be used individually, as labeled, they can no longer be used in combination.”
The CVM said existing stocks of manufactured medicated feed containing this drug combination can be used according to labeled instructions.