The FDA has announced the voluntary withdrawal of 16 antimicrobials for use in food-producing animals.
The US Food and Drug Administration (FDA) announced that five drug sponsors holding animal drug applications affected by Guidance For Industry (GFI) #213 have requested that FDA withdraw approval of a collective 19 animal drug applications because the products are no longer manufactured or marketed.
Of these 19 applications, 16 are antimicrobials affected by GFI #213. The guidance outlines FDA’s plan to help curb antimicrobial resistance by, among other things, phasing out the use of medically important antimicrobials in food-producing animals for production purposes.
1 Denotes applications that were identified by FDA as being affected by Guidance For Industry (GFI) #213, “New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209”, December 2013.
FDA will update its chart of “Applications Affected by GFI #213” to reflect these withdrawals.
The following companies have requested that FDA withdraw approval for their listed products: