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Antimicrobials Voluntarily Withdrawn for Use in Food-Producing Animals

14 April 2014

US - Five drug sponsors holding animal drug applications affected by Guidance For Industry (GFI) #213 have called on the US Food and Drug Administration to withdraw approval of 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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