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Drug sponsors request FDA to withdraw drug application approval

Release Date:

The U.S. Food and Drug Administration has 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 byGFI #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.

  • Gilt Edge TYLAN (tylosin phosphate) Mix
  • HFA Tylosin-10 Plus Sulfa (tylosin phosphate and sulfamethazine)
  • Good Life TYLAN 10 (tylosin phosphate) Premix
  • HFA HYGROMIX 0.48 (hygromycin B) Medicated Premix
  • TYLAN 5 Sulfa (tylosin phosphate and sulfamethazine) Premix

Micro Beef Technologies LTD

  • TYLAN 40 or 100 (tylosin phosphate)

Ridley Feed Ingredients

  • Waynextra for Swine (tylosin phosphate)
  • TYLAN Sulfa-G (tylosin phosphate and sulfamethazine)
  • Ban-A-Worm II (pyrantel tartrate)

Provimi North America Inc.

  • TYLAN 5, 10, 20, or 40 (tylosin phosphate)
  • WORM-BAN 5 or 10 (pyrantel tartrate)
  • HYGROMIX 0.6 (hygromycin B)
  • FLAVOMYCIN 0.4 or 2 (bambermycins)
  • STAFAC 10 (virginiamycin)

Virbac AH Inc.

  • PURINA HYGROMIX (hygromycin B) for Swine
  • PURINA Pork-Plus (tylosin phosphate and sulfamethazine)
  • PURINA Hog Plus II (tylosin phosphate)
  • PURINA TYLAN 40 (tylosin) Plus Sulfamethazine
  • PURINA Check-R-Ton Ll. (lincomycin hydrochloride)