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Department of Health and Human Services Food and Drug Administration 21 CFR Parts 510, 516, 520, 522, 524, 529, 556, and 558 [Docket No. FDA-2024-N-0002]
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule; technical amendments.
SUMMARY:
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during April, May, and June 2024. The animal drug regulations are also being amended to improve their accuracy and readability.
DATES:
This rule is effective October 28, 2024.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-5689, George.Haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Approvals
FDA is amending the animal drug regulations to reflect approval actions for NADAs, ANADAs, and CNADAs during April, May, and June 2024, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOIA Summaries) under the Freedom of Information Act (FOIA). These documents, along with marketing exclusivity and patent information, may be obtained at Animal Drugs @FDA: https://animaldrugsatfda.fda.gov/adafda/views/#/search.
Table 1—Original and Supplemental NADAs, ANADAs, and CNADAs Approved During April, May, and June 2024 Requiring Evidence of Safety and/or Effectiveness
| Date of approval | File No. | Sponsor (drug labeler code) | Product name | Effect of the action | 21 CFR section |
|---|---|---|---|---|---|
| April 5, 2024 | 141-043 | Zoetis Inc, 333 Portage St., Kalamazoo, MI 49007 (054771) | SYNOVEX CHOICE (trenbolone acetate and estradiol benzoate) and SYNOVEX PRIMER (trenbolone acetate and estradiol benzoate) | Supplemental approval for increased rate of weight gain in growing beef steers and heifers in a dry lot | 522.2478 |
| April 9, 2024 | 141-550 | Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 (058198) | PRADALEX (pradofloxacin injection) | Original approval for treatment of bovine respiratory disease and swine respiratory disease | 522.1860 556.530 |
| April 10, 2024 | 200-777 | Felix Pharmaceuticals PVT Ltd., 25-28 North Wall Quay, Dublin 1, Ireland (086101) | Carprofen Injectable Solution | Original approval as a generic copy of NADA 141-199 | 522.304 |
| April 25, 2024 | 200-728 | Cronus Pharma Specialties India Private Ltd., Plot No. 9(B), Survey No. 99/1, GMR Hyderabad Aviation SEZ Ltd., Mamidipalle Village, Balapur Mandal, Shamshabad, Rangareddy, Hyderabad, Telangana, 500108, India (069043) | PIMOMEDIN (pimobendan) Tablets | Original approval as a generic copy of NADA 141-033 | 520.1780 |
| April 26, 2024 | 141-582 | Warburton Technology Ltd., 36 Fitzwilliam Square, Dublin, Dublin, D02HX82, Ireland (066679) | MULTIMIN 90 (zinc, copper, manganese, and selenium injection) | Original approval as a supplemental source of zinc, copper, manganese, and selenium in cattle | 522.2694 |
| May 8, 2024 | 200-780 | Aurora Pharmaceutical, Inc., 1196 Highway 3 South, Northfield, MN 55057-3009 (051072) | COCCIAID (amprolium) for Calves | Original approval as a generic copy of NADA 013-149 | 520.100 |
| May 9, 2024 | 200-782 | Cronus Pharma Specialties India Private Ltd., Plot No. 9(B), Survey No. 99/1, GMR Hyderabad Aviation SEZ Ltd., Mamidipalle Village, Balapur Mandal, Shamshabad, Rangareddy, Hyderabad, Telangana, 500108, India (069043) | ENROPRO Silver Otic (enrofloxacin/silver sulfadiazine) Otic Emulsion | Original approval as a generic copy of NADA 141-176 | 524.802 |
| May 10, 2024 | 141-577 | Vetoquinol USA, Inc., 4250 N Sylvania Ave., Fort Worth, TX 76137 (017030) | UPCARD-CA1 (torsemide oral solution) | Conditional approval as concurrent therapy with pimobendan, spironolactone, and an angiotensin converting enzyme (ACE) inhibitor for the management of pulmonary edema in dogs with congestive heart failure caused by myxomatous mitral valve disease (MMVD) | 516.2475 |
| May 16, 2024 | 200-781 | Cronus Pharma Specialties India Private Ltd., Plot No. 9(B), Survey No. 99/1, GMR Hyderabad Aviation SEZ Ltd., Mamidipalle Village, Balapur Mandal, Shamshabad, Rangareddy, Hyderabad, Telangana, 500108, India (069043) | FLUNINE (flunixin meglumine injection) | Original approval as a generic copy of NADA 101-479 | 522.970 |
| May 23, 2024 | 131-675 | Intervet, Inc., 126 E Lincoln Ave., Rahway, NJ 07065 (000061) | SAFE-GUARD 20% (fenbendazole) Type A medicated article | Supplemental approval for the treatment and control of cecal worms ( Aulonocephalus spp.) in wild quail | 558.258 |
| June 4, 2024 | 138-255 | Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215 (058005) | Iron Dextran 20% Injection (iron hydrogenated dextran injection) Injectable Solution | Supplemental approval for the prevention or treatment of iron deficiency anemia in nursing piglets | 522.1182 |
| June 11, 2024 | 200-787 | ZyVet Animal Health, Inc., 73 Route 31N, Pennington, NJ 08534 (086117) | Phenylpropanolamine Hydrochloride Chewable Tablets | Original approval for the control of urinary incontinence due to urethral sphincter hypotonus in dogs as a generic copy of NADA 141-324 | 520.1760 |
| June 17, 2024 | 200-785 | Felix Pharmaceuticals PVT Ltd., 25-28 North Wall Quay, Dublin 1, IRELAND | Maropitant Citrate Tablets (maropitant citrate) | Original approval as a generic copy of NADA 141-262 | 520.1315 |
| June 20, 2024 | 200-784 | ZyVet Animal Health, Inc., 73 Route 31N, Pennington, NJ 08534 (086117) | Trimeprazine with prednisolone tablets | Original approval as a generic copy of NADA 012-437 | 520.2604 |
| Firm name and address | Drug labeler code |
|---|---|
| * * * * * * * | |
| Ivaoes Animal Health, 2101 W Atlantic Blvd., Suite 108, Pompano Beach, FL 33069 | 086064 |
| * * * * * * * | |
| Warburton Technology Ltd., 36 Fitzwilliam Square, Dublin 2, Dublin, D02HX82, Ireland | 066679 |
| * * * * * * * |
| Drug labeler code | Firm name and address |
|---|---|
| * * * * * * * | |
| 066679 | Warburton Technology Ltd., 36 Fitzwilliam Square, Dublin 2, Dublin, D02HX82, Ireland. |
| * * * * * * * | |
| 086064 | Ivaoes Animal Health, 2101 W Atlantic Blvd., Suite 108, Pompano Beach, FL 33069. |
| * * * * * * * |
| Species/class | Fenbendazole grams per ton | Indications for use | Limitations | Sponsor |
|---|---|---|---|---|
| * * * * * * * | ||||
| (iv) Wild quail | 90.7 | For the treatment and control of Gastrointestinal worms: cecal worms ( Aulonocephalus spp.) | Feed for 21 consecutive days. Prior withdrawal of feed is not necessary | 000061 |
| Florfenicol in grams/ton of feed | Indications for use | Limitations |
|---|---|---|
| * * * * * * * | ||
| (ii) 182 to 2,724 | Freshwater-reared salmonids: for the control of mortality due to coldwater disease associated with Flavobacterium psychrophilum and furunculosis associated with Aeromonas salmonicida | Feed as a sole ration for 10 consecutive days to deliver 10 to 15 mg florfenicol per kg of fish. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. The effects of florfenicol on reproductive performance have not been determined. Feeds containing florfenicol must be withdrawn 15 days prior to slaughter. |
| * * * * * * * |
| Oxytetracycline amount | Indications for use | Limitations | Sponsor |
|---|---|---|---|
| * * * * * * * | |||
| (iv) 333 to 7,500 g/ton to provide 2.5 to 3.75 g/100 lb of fish/day | 1. Freshwater-reared salmonids: for control of ulcer disease caused by Haemophilus piscium, furunculosis caused by Aeromonas salmonicida, bacterial hemorrhagic septicemia caused by A. hydrophila, and pseudomonas disease | Administer in mixed ration for 10 days. Do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed | 066104 |
| 2. Catfish: for control of bacterial hemorrhagic septicemia caused by A. hydrophila and pseudomonas disease | Administer in mixed ration for 10 days. Do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed. Do not administer when water temperature is below 16.7 °C (62 °F) | 066104 | |
| (v) 500 to 7,500 g/ton to provide 3.75 g/100 lb of fish/day | 1. Freshwater-reared salmonids: for control of mortality due to coldwater disease associated with Flavobacterium psychrophilum or for control of mortality due to columnaris disease associated with Flavobacterium columnare | Administer in mixed ration for 10 days. Do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed | 066104 |
| 2. Freshwater-reared salmonids weighing up to 55 grams: for marking of the skeletal tissue | Feed for 10 days. Immediate release is permitted following last feeding of medicated feed | 066104 | |
| 3. Catfish: for control of mortality due to columnaris disease associated with Flavobacterium columnare | Administer in mixed ration for 10 days. Do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed. Do not administer when water temperature is below 16.7 °C (62 °F) | 066104 | |
| (vi) 1.25 to 25 g/kg to provide 11.35 g/100 lb of fish/day | Pacific salmon not over 30 grams body weight: for marking of the skeletal tissue | Administer medicated feed as the sole ration for 4 consecutive days. Do not liberate for at least 7 days following last feeding of medicated feed | 066104 |
| * * * * * * * |