Voluntary Withdrawal of Antimicrobials for Use in Food-Producing Animals

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.

14 April 2014

3 minute read

North America

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:

NADA	Product Name
ADM Alliance Nutrition, Inc.:
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

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

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

NADA	Product Name
Provimi North America, Inc.:
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)

NADA	Product Name
Virbac AH, Inc.:
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.