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FDA Announces Voluntary Withdrawal of Fenbendazole and Lincomycin Combination for Use in Swine

July 6, 2023

FDA Announces Voluntary Withdrawal of Fenbendazole and Lincomycin Combination for Use in Swine

The Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) is announcing 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. The sponsor requested that CVM withdraw the application. This combination is used for removal of certain internal parasites and for the treatment and control of swine dysentery, and for reduction in the severity of swine mycoplasmal pneumonia. Because lincomycin is a veterinary feed directive (VFD) drug, 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 Because this application has been withdrawn, mixing these two drugs in combination is no longer permitted, and VFD orders authorizing their use in combination may no longer be issued

Fenbendazole and lincomycin are marketed as separate Type A medicated articles. Fenbendazole (SafeGuard) is marketed under NADA 131-675, and lincomycin (Lincomix) is marketed under NADA 097-505. NADA 140-954 provided for the combination of these two medications to be mixed together in swine feed. Withdrawal of NADA 140-954 will mean that swine feed that contains both drugs can no longer be manufactured. Accordingly, veterinarians can no longer issue a VFD for a Type C medicated feed containing both medications. However, both fenbendazole (SafeGuard) and lincomycin (Lincomix) remain available for use individually according to their approved labels. 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

CVM is notifying veterinarians to stop issuing VFDs, feed mills to stop filling orders, and pork producers to stop using these medicated articles in combination for use in swine. Existing stocks of manufactured medicated feed containing this drug combination may be used according to labeled instructions. 

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