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.