News last update:6 Aug 2012

Amendment: VMAC reviews Cefquinome

Amendment: The previous published news item on www.AllAboutFeed.net named "FDA rejects antibiotic for use in beef cattle", dated 16 January contained some incorrect information and has been deleted from this website. Please find the correct information below.

Cefquinome, one of Intervet's antimicrobials was recently reviewed by the "Veterinary Medicine Advisory Committee" (VMAC). The review was initiated by FDA Center of Veterinary Medicine (CVM) with respect to the ongoing approval procedure of cefquinome for the treatment of respiratory disease in cattle.

No public health concerns
There was consensus of the VMAC that the Guidance for Industry 152 was correctly followed for cefquinome and that the overall risk estimate ranking of Medium was appropriate. Irrespective of the Microbial Safety Assessment a slim majority of the committee members present considered the evidence provided as inadequate to prove cefquinome safe with regard to the development of 4th generation cephalosporin resistance and potential transfer of resistance to humans.

Pursue approval activities
Although Intervet is disappointed about this outcome, the company is convinced that cefquinome use in livestock will not create public health concerns due to antimicrobial resistance and food-borne transfer. Consequently, Intervet will continue to pursue approval activities. The opinions and advice of the VMAC will now have to be considered by CVM within the context of the Food, Drug & Cosmetic Act and regulations governing the approval of the product.

About cefquinome
Cefquinome is the active ingredient of various Cobactan® formulations which are licensed in Europe for the treatment of respiratory disease, mastitis, septicemia and foot rot in cattle and/or swine and has a track record of many years of effective and safe use. Intervet, as a responsible sponsor fully supports the prudent use of important antibiotics. Intervet is participating in European (EASSA) and American (NARMS) surveillance programs that monitor the susceptibility of commensal bacteria, which have the potential to become food-borne pathogens. This surveillance data has yet to show any change in resistance patterns from isolates tested to 4th generation cephalosporins, in the more than 10 years 4th generation cephalosporins have been used concurrently in Europe in veterinary and human medicine.

Editor AllAboutFeed

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