The Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) announced on June 30 the voluntary withdrawal of the combination medicated feed containing Safe-Guard (fenbendazole) and Lincomix (lincomycin) for use in pigs. The sponsor requested the agency withdraw the application.
The fenbendazole and lincomycin combination is used for the removal of certain internal parasites, the treatment and control of swine dysentery, and reduction in the severity of swine mycoplasmal pneumonia.
Lincomycin is a veterinary feed directive (VFD) drug, meaning any use of lincomycin, alone or in a combination, in feed requires a VFD order from a licensed veterinarian.
Fenbendazole and lincomycin are marketed as separate Type A medicated articles. Fenbendazole—also known as Safe-Guard— is marketed under new animal drug application (NADA) 131-675, and lincomycin—also known as Lincomix—is marketed under NADA 097-505. NADA 140-954 provided for the combination of these two medications in swine feed.
Because this NADA 140-954 has been withdrawn, mixing these two drugs in feed is no longer permitted, and VFD orders authorizing their use in combination may no longer be issued, the FDA CVM explained on its website. However, both fenbendazole and lincomycin remain available for use individually according to their approved labels. Existing stocks of manufactured medicated feed containing this drug combination may be used according to labeled instructions.
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 in feed for use in swine. Questions about the withdrawal should be sent to AskCVMfda [dot] hhs [dot] gov (AskCVM[at]fda[dot]hhs[dot]gov).