USA- The U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) has announced a voluntary withdrawal of a combination medicated feed for swine under the New Animal Drug Application (NADA) 140-954.
The regulatory authority urges feed mills, veterinarians, and pork producers to stop using Safe-Guard (fenbendazole) and Lincomix (lincomycin) in combination in swine feed.
This combination removes certain internal parasites, treats swine dysentery and reduces the severity of swine mycoplasmal pneumonia.
In 2017, the FDA released guidelines on the use of antibiotics, urging players in the feed industry to stop using medically important antibiotics for growth promotion in animal production.
This guideline is especially important because antimicrobial resistance from animal product consumption has become rampant, making it harder to treat different human infections.
Additionally, the FDA called for stringent veterinary oversight of the antibiotics used to prevent, control, and treat bacterial infections.
Because lincomycin is a veterinary feed directive (VFD) drug, any use of lincomycin, alone or in combination, requires a VFD order from a veterinarian.
While fenbendazole and lincomycin are marketed as separate Type A medicated articles, they are marketed under NADA 131-675 and NADA 097-505, respectively.
Additionally, NADA 140-954 provided for the combination of these two medications in swine feed.
Therefore, the withdrawal of NADA 140-954 means that the manufacture of swine feed containing both drugs is prohibited.
Accordingly, veterinarians can no longer issue a VFD for a Type C medicated feed containing both medications.
However, fenbendazole (SafeGuard) and lincomycin (Lincomix) remain available for use individually, according to their approved labels.
As this application is withdrawn, mixing these two drugs in combination is no longer permitted, and VFD orders authorizing their use in combination remain prohibited.
Therefore, pork producers who manufacture medicated feeds should also be aware of this action. Although these two medicated articles can continue to be utilized individually, as labeled, their combination is no longer permitted.
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.
However, existing stocks of the manufactured medicated feed, containing this drug combination, may be used according to labeled instructions.
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