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FDA Withdrawal Of 16 Antimicrobials For Use In Food-Producing Animals

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.:

NADA

Product Name

091-5821

Gilt Edge TYLAN (tylosin phosphate) Mix

108-4841

HFA Tylosin-10 Plus Sulfa (tylosin phosphate and sulfamethazine)

110-0451

Good Life TYLAN 10 (tylosin phosphate) Premix

110-4391

HFA HYGROMIX 0.48 (hygromycin B) Medicated Premix

128-4111

TYLAN 5 Sulfa (tylosin phosphate and sulfamethazine) Premix

Micro Beef Technologies LTD:

NADA

Product Name

138-1871

TYLAN 40 or 100 (tylosin phosphate)

Ridley Feed Ingredients:
 

NADA

Product 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.:

NADA

Product 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.:

NADA

Product 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)

Source:FDA


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