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 |
|---|
| 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