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  1. Antimicrobial Resistance

List of Approved Medically Important Antimicrobial Drugs Administered in the Feed of Food-Producing Animals that Lack a Defined Duration of Use

List of Approved Medically Important Antimicrobial Drugs Administered in the Feed of Food-Producing Animals that Lack a Defined Duration of Use

Since January 2017, as a result of the implementation of Guidance for Industry (GFI) #213, medically important antimicrobials administered in the feed or water of food-producing animals are only available for use through a licensed veterinarian. However, a limited number of currently approved medically important antimicrobials administered through animal feed include indications that lack a defined duration of use. All new animal drug applications on the list below have been identified as medically important antimicrobial drug products approved for use in feed that have one or more indications without a defined duration of use. There are currently no such products approved for use in water with an undefined duration of use.

Establishing durations of use for these applications is a continuation of FDA’s antimicrobial stewardship efforts. Our primary objective is to update product dosage regimens to better target when and for how long the drug may be used. Defining more targeted durations of use for the affected applications supports the FDA's ongoing efforts to slow the development of antimicrobial resistance by fostering the judicious use of medically important antimicrobial drugs in animals. This important work helps to preserve the effectiveness of these antimicrobials in both veterinary and human medicine and is one of the actions highlighted in CVM’s five-year plan for supporting antimicrobial stewardship in veterinary settings.

By the end of September 2020, we intend to publish a draft strategy, likely in the form of a draft guidance document, that addresses how to establish defined durations of use for the affected applications identified in the below list. We expect this draft guidance will outline a proposed process, including time periods, sponsors can follow to revise the approved conditions of use accordingly.

FDA intends to seek public comment on the draft strategy (guidance document) prior to finalization and implementation. Given the significant scientific and technical challenges, including the potential need to generate appropriate supporting information/data, we anticipate that this initiative will require a substantial period of time to fully complete.

Type of Application Application Number Sponsor Ingredient(s) Action(s)
Pioneer Type A medicated article 006-391 Huvepharma EOOD Sulfaquinoxaline   
Pioneer Type A medicated article 008-804 Phibro Animal Health Corp. Oxytetracycline  
Pioneer Type A medicated article 010-918 Elanco US, Inc. Hygromycin B  
Pioneer Type A medicated article 011-948 Elanco US, Inc. Hygromycin B  
Pioneer Type A medicated article 012-491 Elanco US, Inc. Tylosin  
Pioneer Type A medicated article 035-688 Zoetis Inc. Chlortetracycline, Sulfamethazine  
Pioneer Type A medicated article 040-209 Zoetis Inc. Ormetoprim, Sulfadimethoxine  
Pioneer Type A medicated article 041-275 Elanco US, Inc. Tylosin, Sulfamethazine  
Pioneer Type A medicated article 046-415 Zoetis Inc. Tylosin  
Pioneer Type A medicated article 046-699 Zoetis Inc. Chlortetracycline  
Pioneer Type A medicated article 048-480 Pharmgate LLC Chlortetracycline  
Pioneer Type A medicated article 048-761 Zoetis Inc. Chlortetracycline  
Pioneer Type A medicated article 049-287 Zoetis Inc. Chlortetracycline  
Pioneer Type A medicated article 065-410 Zoetis Inc. Tetracycline  
Pioneer Type A medicated article 091-467 Phibro Animal Health Corp. Virginiamycin  
Pioneer Type A medicated article 091-749 Zoetis Inc. Sulfamethazine, Tylosin  
Pioneer Type A medicated article 092-286 Phibro Animal Health Corp. Chlortetracycline  
Pioneer Type A medicated article 094-975 Phibro Animal Health Corp. Neomycin, Oxytetracycline  
Pioneer Type A medicated article 095-143 Phibro Animal Health Corp. Oxytetracycline  
Pioneer Type A medicated article 097-505 Zoetis Inc. Lincomycin  
Pioneer Type A medicated article 098-431 Phibro Animal Health Corp. Tylosin  
Pioneer Type A medicated article 138-934 Pharmgate LLC Chlortetracycline, Sulfamethazine  
Pioneer Type A medicated article 138-935 Pharmgate LLC Chlortetracycline  
Pioneer Type A medicated article 138-938 Pharmgate LLC Oxytetracycline  
Pioneer Type A medicated article 138-939 Pharmgate LLC Neomycin, Oxytetracycline  
Pioneer Type A medicated article 140-998 Phibro Animal Health Corp. Virginiamycin  
Generic Type A medicated article 200-484 Huvepharma EOOD Tylosin  
Generic Type A medicated article 200-510 Pharmgate LLC Chlortetracycline  
Pioneer combination medicated feed 045-444 Zoetis Inc. Chlortetracycline, Decoquinate  
Pioneer combination medicated feed 046-718 Zoetis Inc. Oxytetracycline, Melengestrol  
Pioneer combination medicated feed 046-719 Zoetis Inc. Oxytetracycline, Melengestrol  
Pioneer combination medicated feed 092-507 Zoetis Inc. Chlortetracycline, Robenidine  
Pioneer combination medicated feed 099-006 Phibro Animal Health Corp. Oxytetracycline, Monensin  
Pioneer combination medicated feed 104-646 Elanco US, Inc. Tylosin, Monensin  
Pioneer combination medicated feed 110-047 Phibro Animal Health Corp. Tylosin, Pyrantel  
Pioneer combination medicated feed 116-044 Phibro Animal Health Corp. Lincomycin, Pyrantel  
Pioneer combination medicated feed 138-870 Zoetis Inc. Tylosin, Melengestrol, Monensin  
Pioneer combination medicated feed 138-992 Zoetis Inc. Tylosin, Lasalocid, Melengestrol  
Pioneer combination medicated feed 138-995 Zoetis Inc. Tylosin, Melengestrol  
Pioneer combination medicated feed 139-192 Zoetis Inc. Tylosin, Melengestrol  
Pioneer combination medicated feed 140-579 Zoetis Inc. Oxytetracycline, Lasalocid  
Pioneer combination medicated feed 140-9541 Intervet, Inc. Lincomycin, Fenbendazole  
Pioneer combination medicated feed 141-114 Phibro Animal Health Corp. Virginiamycin, Semduramicin  
Pioneer combination medicated feed 141-149 Zoetis Inc. Tylosin, Monensin, Decoquinate  
Pioneer combination medicated feed 141-1721 Elanco US, Inc. Tylosin, Ractopamine  
Pioneer combination medicated feed 141-1851 Zoetis Inc. Chlortetracycline, Decoquinate  
Pioneer combination medicated feed 141-201 Zoetis Inc. Chlortetracycline, Laidlomycin  
Pioneer combination medicated feed 141-2241 Elanco US, Inc. Tylosin, Monensin, Ractopamine  
Pioneer combination medicated feed 141-2331 Elanco US, Inc. Tylosin, Monensin, Ractopamine, Melengestrol  
Pioneer combination medicated feed 141-250 Zoetis Inc. Chlortetracycline, Lasalocid  
Pioneer combination medicated feed 141-289 Phibro Animal Health Corp. Virginiamycin, Semduramicin  
Pioneer combination medicated feed 141-430 Phibro Animal Health Corp. Virginiamycin, Monensin  
Pioneer combination medicated feed 141-468 Phibro Animal Health Corp. Virginiamycin, Salinomycin  
Pioneer combination medicated feed 141-469 Phibro Animal Health Corp. Virginiamycin, Amprolium  
Pioneer combination medicated feed 141-470 Phibro Animal Health Corp. Virginiamycin, Lasalocid  
Pioneer combination medicated feed 141-472 Huvepharma EOOD Virginiamycin, Diclazuril  
Pioneer combination medicated feed 141-473 Huvepharma EOOD Lincomycin, Halifuginone  
Pioneer combination medicated feed 141-482 Zoetis Inc. Lincomycin, Robenidine  
Pioneer combination medicated feed 141-483 Zoetis Inc. Lincomycin, Decoquinate  
Pioneer combination medicated feed 141-484 Zoetis Inc. Lincomycin, Salinomycin  
Pioneer combination medicated feed 141-485 Zoetis Inc. Lincomycin, Clopidol  
Pioneer combination medicated feed 141-488 Zoetis Inc. Lincomycin, Lasalocid  
Pioneer combination medicated feed 141-489 Zoetis Inc. Lincomycin, Zoalene  
Pioneer combination medicated feed 141-491 Zoetis Inc. Lincomycin, Monensin  
Pioneer combination medicated feed 141-5122 Elanco US, Inc. Monensin, Tylosin, Lubabegron  
Generic combination medicated feed 200-2421 Zoetis Inc. Chlortetracycline, Bacitracin  
Generic combination medicated feed 200-375 Elanco US, Inc. Tylosin, Melengestrol, Monensin  
Generic combination medicated feed 200-4241 Elanco US, Inc. Tylosin, Monensin, Ractopamine, Melengestrol  
Generic combination medicated feed 200-427 Elanco US, Inc. Tylosin, Melengestrol  
Generic combination medicated feed 200-430 Elanco US, Inc. Tylosin, Lasalocid, Melengestrol  
Generic combination medicated feed 200-4801 Elanco US, Inc. Tylosin, Melengestrol, Monensin, Zilpaterol  
Generic combination medicated feed 200-5301 Huvepharma EOOD Tylosin, Ractopamine  
Generic combination medicated feed 200-531 Huvepharma EOOD Tylosin, Monensin  
Generic combination medicated feed 200-532 Huvepharma EOOD Tylosin, Melengestrol  
Generic combination medicated feed 200-533 Huvepharma EOOD Tylosin, Decoquinate, Monensin  
Generic combination medicated feed 200-534 Huvepharma EOOD Tylosin, Melengestrol, Monensin  
Generic combination medicated feed 200-535 Huvepharma EOOD Tylosin, Melengestrol, Lasalocid  
Generic combination medicated feed 200-5581 Zoetis Inc. Tylosin, Ractopamine  
Generic combination medicated feed 200-5611 Zoetis Inc. Tylosin, Monensin, Ractopamine  
Generic combination medicated feed 200-5621 Zoetis Inc. Tylosin, Monensin, Ractopamine, Melengestrol  
Generic combination medicated feed 200-5661 Huvepharma EOOD Tylosin, Monensin, Ractopamine  
Generic combination medicated feed 200-5671 Huvepharma EOOD Tylosin, Monensin, Ractopamine, Melengestrol  
Generic combination medicated feed 200-5841 Zoetis Inc. Ractopamine, Tylosin  
Generic combination medicated feed 200-617 Pharmgate LLC Chlortetracycline, Lasalocid  
Generic combination medicated feed 200-622 Pharmgate LLC Chlortetracycline, Decoquinate  

1 The regimens for these combination medicated feeds are appropriately defined as currently approved. These applications will require only administrative revisions to one or more labeling components that contain language referencing other undefined regimen(s) that are associated with the reference listed antimicrobial Type A medicated articles.

2 Application approved after April 2019 when this list was initially published.