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Voluntary Withdrawal of Antimicrobials for Use in Food-Producing Animals

15 April 2014

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


Micro Beef Technologies LTD:
NADAProduct Name
138-1871 TYLAN 40 or 100 (tylosin phosphate)


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


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


Virbac AH, Inc.:
NADAProduct Name
013-2141 PURINA HYGROMIX (hygromycin B) for Swine
042-6601 PURINA Pork-Plus (tylosin phosphate and sulfamethazine)
043-3871 PURINA Hog Plus II (tylosin phosphate)
099-7671 PURINA TYLAN 40 (tylosin) Plus Sulfamethazine
132-5741 PURINA 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.

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