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News 2821 views 5 commentslast update:14 Jan 2016

FDA: withdrawal of 16 antimicrobials for use in food animals

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:

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  • FDA: withdrawal of 16 antimicrobials for use in food animals
  • FDA: withdrawal of 16 antimicrobials for use in food animals

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5 comments

  • Youssef Attia

    I think that they will be more antimicrobial withdrawal in future and natural alternative to antimicrobial will be more likely in use in future

  • Dr. Agrawal

    What is the alternative?

  • Arnold Sinurat

    Any scientific reasons why they are not produced and marketed anymore?

  • joshua jendza

    Probably not. Most likely they were pulled because of poor sales. For example, many of them appear at first glance to be blend downs containing different cocentrations of Tylan, which I believe is still on the market in other forms.

  • Larry Whetstone

    Swine and poultry can be protected with soluble fibre extracted from Chicory , or Jerusalem Artichoke. JA may be grown and tops harvested 2 - 3 times a year for production of a silage aditive for addition to enhance gut health by producing short chain fatty acids and create an ACID Gut to protect animal life , thus ending the use of antibiotic in feeds. lwhetstone@canuksales.com

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