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  1. Judicious Use of Antimicrobials

List of Approved New Animal Drug Applications Affected by Draft GFI #263

Since 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 draft 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.

FDA is proposing a two-year implementation period that would begin after the agency considers comments on the draft guidance and issues the final guidance. In addition, the FDA plans to engage with affected stakeholders and state partners at public events, such as meetings and conferences, to hear feedback and answer questions about the changes proposed in the draft guidance document.  

Type of Application Application Number Sponsor Ingredient(s) Action
Pioneer 007-981 Zoetis Inc. Sulfisoxazole  
Pioneer 008-763 Zoetis Inc. Oxytetracycline, Polymyxin B  
Pioneer 008-769 Zoetis Inc. Oxytetracycline  
Pioneer 008-774 Huvepharma EOOD Sulfamethazine  
Pioneer 011-060 Zoetis Inc. Oxytetracycline  
Pioneer 011-154 Neogen Corporation Nitrofurazone  
Pioneer 011-532 Boehringer Ingelheim Animal Health USA Sulfabromomethazine  
Pioneer 011-948 Elanco US Inc. Hygromycin B  
Pioneer 012-123 Bimeda Animal Health Ltd Erythromycin  
Pioneer 012-965 Elanco US Inc. Tylosin  
Pioneer 031-715 Zoetis Inc. Sulfadimethoxine  
Pioneer 031-944 Zoetis Inc. Sulfomyxin  
Pioneer 032-319 Kinetic Technologies LLC Furazolidone  
Pioneer 033-127 Boehringer Ingelheim Animal Health USA Sulfachlorpyridazine  
Pioneer 033-157 Huvepharma EOOD Spectinomycin  
Pioneer 033-318 Boehringer Ingelheim Animal Health USA Sulfachlorpyridazine  
Pioneer 034-025 Zoetis Inc. Lincomycin  
Pioneer 035-455 Bimeda Animal Health Ltd Erythromycin  
Pioneer 035-456 Bimeda Animal Health Ltd Erythromycin  
Pioneer 037-586 Zoetis Inc. Erythromycin  
Pioneer 040-040 Huvepharma EOOD Spectinomycin  
Pioneer 040-181 Huvepharma EOOD Sulfachlorpyridazine  
Pioneer 041-245 Zoetis Inc. Sulfadimethoxine  
Pioneer 041-629 Zoetis Inc. Spectinomycin  
Pioneer 045-143 Cronus Pharma Specialties India Private Ltd Oxytetracycline  
Pioneer 047-278 Cronus Pharma Specialties India Private Ltd Oxytetracycline  
Pioneer 048-287 Huvepharma EOOD Oxytetracycline  
Pioneer 055-018 Huvepharma EOOD Chlortetracycline  
Pioneer 055-039 Huvepharma EOOD Chlortetracycline  
Pioneer 055-072 Zoetis Inc. Penicillin G Procaine, Novobiocin  
Pioneer 055-097 HQ Specialty Pharma Corporation Dihydrostreptomycin, Penicillin G Procaine  
Pioneer 055-098 Zoetis Inc. Penicillin G Procaine, Novobiocin  
Pioneer 065-004 Zoetis Inc. Tetracycline  
Pioneer 065-010 Norbrook Laboratories, Ltd. Penicillin G Procaine  
Pioneer 065-013 Norbrook Laboratories, Ltd. Dihydrostreptomycin  
Pioneer 065-081 G.C. Hanford Mfg. Co. Penicillin G Procaine  
Pioneer 065-110 Huvepharma EOOD Penicillin G Procaine  
Pioneer 065-124 Zoetis Inc. Tetracycline  
Pioneer 065-130 Zoetis Inc. Penicillin G Procaine  
Pioneer 065-169 Zoetis Inc. Penicillin G Benzathine, Penicillin G Procaine  
Pioneer 065-174 Zoetis Inc. Penicillin G Procaine  
Pioneer 065-270 Zoetis Inc. Tetracycline  
Pioneer 065-383 Bimeda Animal Health Ltd Penicillin G Procaine  
Pioneer 065-481 Cronus Pharma Specialties India Private Ltd Chlortetracycline  
Pioneer 065-493 Norbrook Laboratories, Ltd. Penicillin G Procaine  
Pioneer 065-498 Huvepharma EOOD Penicillin G Benzathine, Penicillin G Procaine  
Pioneer 065-500 Norbrook Laboratories, Ltd. Penicillin G Benzathine, Penicillin G Procaine  
Pioneer 065-505 Bimeda Animal Health Ltd. Penicillin G Procaine  
Pioneer 065-506 Bimeda Animal Health Ltd. Penicillin G Benzathine, Penicillin G Procaine  
Pioneer 091-127 Zoetis Inc. Oxytetracycline  
Pioneer 092-523 Intervet, Inc. Gentamicin  
Pioneer 093-329 Bayer HealthCare LLC, Animal Health Division Sulfamethazine  
Pioneer 094-114 Zoetis Inc. Oxytetracycline  
Pioneer 095-642 Boehringer Ingelheim Animal Health USA Oxytetracycline  
Pioneer 097-222 Boehringer Ingelheim Animal Health USA Cephapirin  
Pioneer 097-452 Cronus Pharma Specialties India Private Ltd Oxytetracycline  
Pioneer 099-402 Zoetis Inc. Oxytetracycline  
Pioneer 100-854 Farnam Companies, Inc. Nitrofurazone  
Pioneer 101-862 Intervet, Inc. Gentamicin  
Pioneer 103-037 Intervet, Inc. Gentamicin  
Pioneer 108-114 Boehringer Ingelheim Animal Health USA Cephapirin Benzathine  
Pioneer 108-963 Cronus Pharma Specialties India Private Ltd Oxytetracycline  
Pioneer 111-104 Farnam Companies, Inc. Furazolidone  
Pioneer 113-232 Zoetis Inc. Oxytetracycline  
Pioneer 120-615 Bimeda Animal Health Ltd Sulfamethazine  
Pioneer 122-271 Huvepharma EOOD Sulfamethazine  
Pioneer 122-447 Bimeda Animal Health Ltd Nitrofurazone  
Pioneer 125-797 Cronus Pharma Specialties India Private Ltd Nitrofurazone  
Pioneer 126-236 Cronus Pharma Specialties India Private Ltd Nitrofurazone  
Pioneer 126-504 Bimeda Animal Health Ltd Nitrofurazone  
Pioneer 130-464 Intervet, Inc. Gentamicin  
Pioneer 130-872 Med-Pharmex Inc. Nitrofurazone, Butacaine  
Pioneer 130-952 Intervet, Inc. Gentamicin  
Pioneer 132-427 Squire Laboratories, Inc. Nitrofurazone  
Pioneer 138-657 Sparhawk Laboratories, Inc. Nitrofurazone  
Pioneer 138-955 Huvepharma EOOD Tylosin  
Pioneer 140-270 Huvepharma EOOD Sulfamethazine  
Pioneer 140-582 Bimeda Animal Health Ltd. Oxytetracycline  
Pioneer 140-851 Neogen Corporation Nitrofurazone  
Pioneer 140-881 Med-Pharmex, Inc. Nitrofurazone  
Pioneer 140-908 Lloyd, Inc. Sulfamethazine  
Pioneer 140-909 Zoetis Inc. Sulfamethazine  
Pioneer 141-002 Boehringer Ingelheim Animal Health USA Oxytetracycline  
Pioneer 141-143 Norbrook Laboratories, Ltd. Oxytetracycline  
Generic 200-008 Boehringer Ingelheim Animal Health USA Oxytetracycline  
Generic 200-038 Huvepharma EOOD Sulfadimethoxine  
Generic 200-068 Huvepharma EOOD Oxytetracycline  
Generic 200-117 Bimeda Animal Health Ltd. Oxytetracycline  
Generic 200-123 Huvepharma EOOD Oxytetracycline  
Generic 200-127 Zoetis Inc. Spectinomycin  
Generic 200-128 Huvepharma EOOD Oxytetracycline  
Generic 200-147 Huvepharma EOOD Gentamicin  
Generic 200-154 Pharmgate Inc. Oxytetracycline  
Generic 200-174 Huvepharma EOOD Gentamicin  
Generic 200-191 Med-Pharmex Inc. Gentamicin  
Generic 200-274 Zoetis Inc. Lincomycin  
Generic 200-306 Norbrook Laboratories, Ltd. Oxytetracycline  
Generic 200-315 Sparhawk Laboratories, Inc. Lincomycin  
Generic 200-351 Huvepharma EOOD Lincomycin  
Generic 200-364 Bimeda Animal Health Ltd. Spectinomycin  
Generic 200-368 Bimeda Animal Health Ltd. Lincomycin  
Generic 200-394 Sparhawk Laboratories, Inc. Gentamicin  
Generic 200-425 First Priority, Inc. Nitrofurazone  
Generic 200-452 Norbrook Laboratories, Ltd. Oxytetracycline  
Generic 200-468 Bimeda Animal Health Ltd. Gentamicin  
Generic 200-508 Bimeda Animal Health Ltd. Tylosin  
Generic 200-523 Bimeda Animal Health Ltd. Sulfadimethoxine  
Generic 200-537 Bimeda Animal Health Ltd. Oxytetracycline