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  5. List of Approved New Animal Drug Applications Affected by GFI #263
  1. Antimicrobial Resistance

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Pioneer 011-532 Boehringer Ingelheim Animal Health USA Sulfabromomethazine Application Voluntarily Withdrawn 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Pioneer 033-127 Boehringer Ingelheim Animal Health USA Sulfachlorpyridazine Application Voluntarily Withdrawn 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Pioneer 033-318 Boehringer Ingelheim Animal Health USA Sulfachlorpyridazine Application Voluntarily Withdrawn 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

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