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 In this section:

                Antimicrobial Resistance

Antimicrobial Resistance

                        


                        The National Antimicrobial Resistance Monitoring System Home
          Animal & Veterinary
          Safety & Health
          Antimicrobial Resistance
          List of Approved New Animal Drug Applications Affected by GFI #263Antimicrobial Resistance List of Approved New Animal Drug Applications Affected by GFI #263
  
  	
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    PrintSince January 2017, as a result of the successful implementation of Guidance for Industry (GFI) #213, medically important antimicrobials administered in the feed or drinking water of food-producing animals are only available for use through a licensed veterinarian. However, a limited number of other dosage forms (e.g. injectables) of approved medically important antimicrobials remain available over-the-counter (OTC).  All new animal drug applications on the list below have been identified as medically important antimicrobial drugs that currently remain approved as over-the-counter products.

The listed applications are affected by GFI #263, “Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter.”  The  voluntary process outlined in this guidance is part of FDA’s broader efforts to support antimicrobial stewardship and slow the development of antimicrobial resistance.

GFI #263 has a two-year implementation period that begins June 11, 2021. To provide for a more predictable timeline for when revised (prescription) labels are expected to enter the market, we’ve asked that the affected drug companies make plans to ensure that, after June 11, 2023, all new product entering distribution channels be labeled as prescription products. FDA intends to allow existing inventory of OTC-labeled product that may already be in distribution channels to deplete.

June 11, 2023, is our target date to introduce new Rx labeled products into the marketplace.

To ensure the success of GFI #263, FDA plans to continue coordinating with the animal pharmaceutical industry and other key stakeholders to develop an implementation strategy for bringing all remaining dosage forms of medically important antimicrobials under the oversight of licensed veterinarians.

Type of Application
			Application Number
			Sponsor
			Ingredient(s)
			ActionPioneer
			007-981
			Zoetis Inc.
			Sulfisoxazole
			Supplement ApprovedPioneer
			008-763
			Zoetis Inc.
			Oxytetracycline, Polymyxin B
			Supplement ApprovedPioneer
			008-769
			Zoetis Inc.
			Oxytetracycline
			Supplement ApprovedPioneer
			008-774
			Huvepharma EOOD
			Sulfamethazine
			Supplement ApprovedPioneer
			011-060
			Zoetis Inc.
			Oxytetracycline
			Supplement ApprovedPioneer
			011-532
			Boehringer Ingelheim Animal Health USA
			Sulfabromomethazine
			Application Voluntarily WithdrawnPioneer
			012-123
			Bimeda Animal Health Ltd
			Erythromycin
			Supplement ApprovedPioneer
			012-965
			Elanco US Inc.
			Tylosin
			Supplement ApprovedPioneer
			031-715
			Zoetis Inc.
			Sulfadimethoxine
			Supplement ApprovedPioneer
			031-944
			Zoetis Inc.
			Sulfomyxin
			Supplement ApprovedPioneer
			033-127
			Boehringer Ingelheim Animal Health USA
			Sulfachlorpyridazine
			Application Voluntarily WithdrawnPioneer
			033-157
			Huvepharma EOOD
			Spectinomycin
			Supplement ApprovedPioneer
			033-318
			Boehringer Ingelheim Animal Health USA
			Sulfachlorpyridazine
			Application Voluntarily WithdrawnPioneer
			034-025
			Zoetis Inc.
			Lincomycin
			Supplement ApprovedPioneer
			035-455
			Bimeda Animal Health Ltd
			Erythromycin
			Supplement ApprovedPioneer
			035-456
			Bimeda Animal Health Ltd
			Erythromycin
			Supplement ApprovedPioneer
			037-586
			Zoetis Inc.
			Erythromycin
			Supplement ApprovedPioneer
			040-040
			Huvepharma EOOD
			Spectinomycin
			Supplement ApprovedPioneer
			040-181
			Huvepharma EOOD
			Sulfachlorpyridazine
			Supplement ApprovedPioneer
			041-245
			Zoetis Inc.
			Sulfadimethoxine
			Supplement ApprovedPioneer
			041-629
			Zoetis Inc.
			Spectinomycin
			Supplement ApprovedPioneer
			045-143
			Cronus Pharma Specialties India Private Ltd
			Oxytetracycline
			Supplement ApprovedPioneer
			047-278
			Cronus Pharma Specialties India Private Ltd
			Oxytetracycline
			Supplement ApprovedPioneer
			048-287
			Huvepharma EOOD
			Oxytetracycline
			Supplement ApprovedPioneer
			055-018
			Huvepharma EOOD
			Chlortetracycline
			Supplement ApprovedPioneer
			055-039
			Huvepharma EOOD
			Chlortetracycline
			Supplement ApprovedPioneer
			055-072
			Zoetis Inc.
			Penicillin G Procaine, Novobiocin
			Supplement ApprovedPioneer
			055-097
			HQ Specialty Pharma Corporation
			Dihydrostreptomycin, Penicillin G Procaine
			Supplement ApprovedPioneer
			055-098
			Zoetis Inc.
			Penicillin G Procaine, Novobiocin
			Supplement ApprovedPioneer
			065-004
			Zoetis Inc.
			Tetracycline
			Supplement ApprovedPioneer
			065-010
			Norbrook Laboratories, Ltd.
			Penicillin G Procaine
			Supplement ApprovedPioneer
			065-013
			Norbrook Laboratories, Ltd.
			Dihydrostreptomycin
			Application Voluntarily WithdrawnPioneer
			065-081
			HQ Specialty Pharma Corp.
			Penicillin G Procaine
			Supplement ApprovedPioneer
			065-110
			Huvepharma EOOD
			Penicillin G Procaine
			Supplement ApprovedPioneer
			065-124
			Zoetis Inc.
			Tetracycline
			Supplement ApprovedPioneer
			065-130
			Zoetis Inc.
			Penicillin G Procaine
			Supplement ApprovedPioneer
			065-169
			Zoetis Inc.
			Penicillin G Benzathine, Penicillin G Procaine
			Supplement ApprovedPioneer
			065-174
			Zoetis Inc.
			Penicillin G Procaine
			Supplement ApprovedPioneer
			065-270
			Zoetis Inc.
			Tetracycline
			Supplement ApprovedPioneer
			065-383
			Bimeda Animal Health Ltd
			Penicillin G Procaine
			Supplement ApprovedPioneer
			065-481
			Cronus Pharma Specialties India Private Ltd
			Chlortetracycline
			Supplement ApprovedPioneer
			065-493
			Norbrook Laboratories, Ltd.
			Penicillin G Procaine
			Application Voluntarily WithdrawnPioneer
			065-498
			Huvepharma EOOD
			Penicillin G Benzathine, Penicillin G Procaine
			Supplement ApprovedPioneer
			065-500
			Norbrook Laboratories, Ltd.
			Penicillin G Benzathine, Penicillin G Procaine
			Application Voluntarily WithdrawnPioneer
			065-505
			Bimeda Animal Health Ltd.
			Penicillin G Procaine
			Supplement ApprovedPioneer
			065-506
			Bimeda Animal Health Ltd.
			Penicillin G Benzathine, Penicillin G Procaine
			Supplement ApprovedPioneer
			091-127
			Zoetis Inc.
			Oxytetracycline
			Supplement ApprovedPioneer
			092-523
			Intervet, Inc.
			Gentamicin
			Supplement ApprovedPioneer
			093-329
			Elanco US Inc.
			Sulfamethazine
			Application Voluntarily WithdrawnPioneer
			094-114
			Zoetis Inc.
			Oxytetracycline
			Supplement ApprovedPioneer
			095-642
			Boehringer Ingelheim Animal Health USA
			Oxytetracycline
			Application Voluntarily WithdrawnPioneer
			097-222
			Boehringer Ingelheim Animal Health USA
			Cephapirin
			Supplement ApprovedPioneer
			097-452
			Cronus Pharma Specialties India Private Ltd
			Oxytetracycline
			Supplement ApprovedPioneer
			099-402
			Zoetis Inc.
			Oxytetracycline
			Supplement ApprovedPioneer
			101-862
			Intervet, Inc.
			Gentamicin
			Supplement ApprovedPioneer
			103-037
			Intervet, Inc.
			Gentamicin
			Supplement ApprovedPioneer
			108-114
			Boehringer Ingelheim Animal Health USA
			Cephapirin Benzathine
			Supplement ApprovedPioneer
			108-963
			Cronus Pharma Specialties India Private Ltd
			Oxytetracycline
			Supplement ApprovedPioneer
			110-315*
			Elanco US Inc.
			Tylosin
			Supplement ApprovedPioneer
			113-232
			Zoetis Inc.
			Oxytetracycline
			Supplement ApprovedPioneer
			118-123*
			Elanco US Inc.
			Oxytetracycline
			Supplement ApprovedPioneer
			120-615
			Bimeda Animal Health Ltd
			Sulfamethazine
			Supplement ApprovedPioneer
			122-271
			Huvepharma EOOD
			Sulfamethazine
			Supplement ApprovedPioneer
			130-464
			Intervet, Inc.
			Gentamicin
			Supplement ApprovedPioneer
			130-952
			Intervet, Inc.
			Gentamicin
			Supplement ApprovedPioneer
			135-906*
			Elanco US Inc.
			Tylosin
			Supplement ApprovedPioneer
			138-955
			Huvepharma EOOD
			Tylosin
			Supplement ApprovedPioneer
			140-270
			Huvepharma EOOD
			Sulfamethazine
			Supplement ApprovedPioneer
			140-582
			Bimeda Animal Health Ltd.
			Oxytetracycline
			Supplement ApprovedPioneer
			140-908
			Lloyd, Inc.
			Sulfamethazine
			Application Voluntarily WithdrawnPioneer
			140-909
			Zoetis Inc.
			Sulfamethazine
			Supplement ApprovedPioneer
			141-002
			Boehringer Ingelheim Animal Health USA
			Oxytetracycline
			Application Voluntarily WithdrawnPioneer
			141-143
			Norbrook Laboratories, Ltd.
			Oxytetracycline
			Supplement ApprovedGeneric
			200-008
			Boehringer Ingelheim Animal Health USA
			Oxytetracycline
			Supplement ApprovedGeneric
			200-038
			Huvepharma EOOD
			Sulfadimethoxine
			Supplement ApprovedGeneric
			200-068
			Huvepharma EOOD
			Oxytetracycline
			Supplement ApprovedGeneric
			200-117
			Bimeda Animal Health Ltd.
			Oxytetracycline
			Supplement ApprovedGeneric
			200-123
			Huvepharma EOOD
			Oxytetracycline
			Supplement ApprovedGeneric
			200-127
			Zoetis Inc.
			Spectinomycin
			Supplement ApprovedGeneric
			200-128
			Huvepharma EOOD
			Oxytetracycline
			Supplement ApprovedGeneric
			200-147
			Huvepharma EOOD
			Gentamicin
			Supplement ApprovedGeneric
			200-154
			Pharmgate Inc.
			Oxytetracycline
			Supplement ApprovedGeneric
			200-174
			Huvepharma EOOD
			Gentamicin
			Supplement ApprovedGeneric
			200-191
			Med-Pharmex Inc.
			Gentamicin
			Application Voluntarily WithdrawnGeneric
			200-221*
			Elanco US Inc.
			Tylosin
			Supplement ApprovedGeneric
			200-224*
			Elanco US Inc.
			Tylosin
			Supplement ApprovedGeneric
			200-274
			Zoetis Inc.
			Lincomycin
			Supplement ApprovedGeneric
			200-306
			Norbrook Laboratories, Ltd.
			Oxytetracycline
			Supplement ApprovedGeneric
			200-315
			Sparhawk Laboratories, Inc.
			Lincomycin
			Supplement ApprovedGeneric
			200-346*
			Elanco US Inc.
			Tylosin
			Supplement ApprovedGeneric
			200-351
			Huvepharma EOOD
			Lincomycin
			Supplement ApprovedGeneric
			200-364
			Bimeda Animal Health Ltd.
			Spectinomycin
			Supplement ApprovedGeneric
			200-368
			Bimeda Animal Health Ltd.
			Lincomycin
			Supplement ApprovedGeneric
			200-394
			Sparhawk Laboratories, Inc.
			Gentamicin
			Supplement ApprovedGeneric
			200-452
			Norbrook Laboratories, Ltd.
			Oxytetracycline
			Supplement ApprovedGeneric
			200-468
			Bimeda Animal Health Ltd.
			Gentamicin
			Supplement ApprovedGeneric
			200-508
			Bimeda Animal Health Ltd.
			Tylosin
			Supplement ApprovedGeneric
			200-523
			Bimeda Animal Health Ltd.
			Sulfadimethoxine
			Supplement ApprovedGeneric
			200-537
			Bimeda Animal Health Ltd.
			Oxytetracycline
			Supplement Approved



* Products added to the scope of the GFI after June 11, 2021. Consistent with the 2-year timeline outlined in GFI 263, those products have additional time to complete their voluntarily transition from OTC to Rx.

                                                                                  Content current as of:
      11/03/2023Antimicrobial Resistance

          
                        


                        The National Antimicrobial Resistance Monitoring System
 
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