Animal & Veterinary

FDA Announces Voluntary Withdrawal of 16 Antimicrobials for Use in Food-Producing Animals

April 9, 2014

Media Inquiries: Siobhan DeLancey, 202-510-4177, siobhan.delancey@fda.hhs.gov
Trade Press Inquiries: Megan Bensette, 240-506-6818, megan.bensette@fda.hhs.gov 
Consumer and Industry Inquiries: AskCVM@fda.hhs.gov

The U.S. Food and Drug Administration is today announcing 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.

The following companies have requested that FDA withdraw approval for their listed products:

ADM Alliance Nutrition, Inc.:

NADAProduct Name
091-5821Gilt Edge TYLAN (tylosin phosphate) Mix
108-4841HFA Tylosin-10 Plus Sulfa (tylosin phosphate and sulfamethazine)
110-0451Good Life TYLAN 10 (tylosin phosphate) Premix
110-4391HFA HYGROMIX 0.48 (hygromycin B) Medicated Premix
128-4111TYLAN 5 Sulfa (tylosin phosphate and sulfamethazine) Premix

Micro Beef Technologies LTD:

NADAProduct Name
138-1871TYLAN 40 or 100 (tylosin phosphate)

Ridley Feed Ingredients:

NADAProduct Name
099-4681Waynextra for Swine (tylosin phosphate)
131-9581TYLAN Sulfa-G (tylosin phosphate and sulfamethazine)
132-136Ban-A-Worm II (pyrantel tartrate)

Provimi North America, Inc.:

NADAProduct Name
103-0891TYLAN 5, 10, 20, or 40 (tylosin phosphate)
118-814WORM-BAN 5 or 10 (pyrantel tartrate)
127-5081HYGROMIX 0.6 (hygromycin B)
131-413FLAVOMYCIN 0.4 or 2 (bambermycins)
133-3331STAFAC 10 (virginiamycin)

Virbac AH, Inc.:

NADAProduct Name
013-2141PURINA HYGROMIX (hygromycin B) for Swine
042-6601PURINA Pork-Plus (tylosin phosphate and sulfamethazine)
043-3871PURINA Hog Plus II (tylosin phosphate)
099-7671PURINA TYLAN 40 (tylosin) Plus Sulfamethazine
132-5741PURINA Check-R-Ton Ll. (lincomycin hydrochloride)

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.

Contact FDA

240-276-9300
240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855

Page Last Updated: 06/05/2014
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