New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
Federal RegisterAug 22, 2025
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 528, and 558
[Docket No. FDA-2025-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
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) and abbreviated new animal drug applications (ANADAs) during April, May, and June 2025. The animal drug regulations are also being amended to improve their accuracy and readability.
DATES:
This rule is effective August 22, 2025.
FOR FURTHER INFORMATION CONTACT:
Cathie Marshall, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-5693,
cathie.marshall@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Approval of Applications
FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during April, May, and June 2025, as listed in table 1. Documentation of environmental review required under the National Environmental Policy Act, summaries of the basis of approval under the Freedom of Information Act (FOIA summaries), and marketing exclusivity and patent information are available at Animal Drugs @FDA:
https://animaldrugsatfda.fda.gov/adafda/views/#/search.
Table 1—Original And Supplemental Applications Approved During April, May, and June 2025
Date of approval
Application No.
Sponsor
(drug labeler code
1
)
Product name
Effect of the
action
21 CFR
sections
March 24, 2025
2
200-811
Bimeda Animal Health Ltd. (061133)
MOXICLOPRID for Cats (imidacloprid and moxidectin) Topical Solution
Original approval as a generic copy of NADA 141-254
524.1146
March 24, 2025
3
200-810
Hikma Pharmaceuticals USA, Inc. (086194)
Enrofloxacin Flavored Tablets (enrofloxacin flavored tablets)
Original approval as a generic copy of NADA 140-441
520.812
April 3, 2025
200-791
Cronus Pharmaceuticals Specialities India Private Ltd. (069043)
FLUNINE-S (flunixin meglumine injection) Injectable Solution
Original approval as a generic copy of NADA 101-479
522.970
April 7, 2025
141-586
Phibro Animal Health Corp. (066104)
V-MAX (virginiamycin), RUMENSIN (monensin), and EXPERIOR (lubabegron) Type A medicated articles to be used in the manufacture of Type B and Type C medicated cattle feed
Original approval
558.635
April 7, 2025
141-588
Phibro Animal Health Corp. (066104)
V-MAX (virginiamycin) and RUMENSIN (monensin) Type A medicated articles to be used in the manufacture of Type B/C medicated cattle feeds
Original approval
558.635
April 8, 2025
141-587
Phibro Animal Health Corp. (066104)
V-MAX (virginiamycin), RUMENSIN (monensin), and OPTAFLEXX (ractopamine hydrochloride) Type A medicated articles to be used in the manufacture of Type B/C medicated cattle feeds
Original approval
558.635
April 8, 2025
141-521
Zoetis Inc (054771)
SIMPARICA TRIO (sarolaner, moxidectin, and pyrantel chewable tablets) Chewable Tablets
Supplemental approval
520.2090
April 10, 2025
141-598
Dechra Ltd. (043264)
OTISERENE (marbofloxacin terbinafine dexamethasone otic suspension)
Original approval
524.1312
April 23, 2025
141-554
Boehringer Ingelheim Animal Health USA, Inc.(000010)
NEXGARD PLUS (afoxolaner, moxidectin, and pyrantel chewable tablets)
Supplemental approval
520.35
April 24, 2025
200-797
Huvepharma EOOD
(016592)
COXIDIN (monensin) and BMD (bacitracin methylenedisalicylate) Type A medicated articles to be used in the manufacture of Type C medicated broiler feeds
Original approval as a generic copy of NADA 049-463
558.355
April 24, 2025
200-798
Huvepharma EOOD (016592)
COXIDIN (monensin) and FLAVOMYCIN (bambermycins) Type A medicated articles to be used in the manufacture of Type C medicated broiler feeds
Original approval as a generic copy of NADA 098-340
558.355
April 24, 2025
200-799
Huvepharma EOOD (016592)
COXIDIN (monensin) and BMD (bacitracin methylenedisalicylate) Type A medicated articles to be used in the manufacture of Type C medicated turkey feeds
Original approval as a generic copy of NADA 140-937
558.355
April 24, 2025
200-800
Huvepharma EOOD (016592)
COXIDIN (monensin) and FLAVOMYCIN (bambermycins) Type A medicated articles to be used in the manufacture of Type C medicated turkey feeds
Original approval as a generic copy of NADA 140-955
558.355
April 24, 2025
200-801
Huvepharma EOOD (016592)
COXIDIN (monensin) and INTEPRITY (avilamycin) Type A medicated articles to be used in the manufacture of Type C medicated broiler feeds
Original approval as a generic copy of NADA 141-465
558.68
April 24, 2025
200-802
Huvepharma EOOD (016592)
COXIDIN (monensin) and PENNITRACIN MD (bacitracin methylenedisalicylate) Type A medicated articles to be used in the manufacture of Type C medicated turkey feeds
Original approval as a generic copy of NADA 141-540
558.355
April 29, 2025
141-609
Genus plc (086205)
DELETION OF EXON 7 OF CD163 GENE IN DOMESTIC PIGS (Deletion of exon 7 of CD163 gene in domestic pigs)
Original approval
528.2000
April 29, 2025
141-600
Intervet (000061)
MOMETAMAX SINGLE (gentamicin, posaconazole, and mometasone furoate otic suspension)
Original approval
524.1044j
May 21, 2025
141-581
Elanco US Inc. (058198)
CREDELIO QUATTRO (lotilaner, moxidectin, praziquantel, and pyrantel)
Supplemental approval
520.1287
June 24, 2025
200-812
Qilu Animal Health Products Co., Ltd. (086163)
Cefovecin Sodium for Injection (cefovecin sodium)
Original approval as a generic copy of NADA 141-285
522.311
June 27, 2025
200-813
Felix Pharmaceuticals Pvt. Ltd. (086101)
Clindamycin Hydrochloride Tablets (clindamycin hydrochloride)
Original approval as a generic copy of NADA 120-161
520.446
June 27, 2025
200-814
Felix Pharmaceuticals Pvt. Ltd. (086101)
Methimazole Coated Tablets (methimazole tablets)
Original approval as a generic copy of NADA 141-292
520.1375
1
See 21 CFR 510.600(c) for sponsor addresses.
2
Approved in the first quarter of 2025.
3
Ibid.
II. Withdrawal of Approval of Applications
Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom (drug labeler code 043264) requested that FDA withdraw approval of one NADA listed in table 2 because the product was never manufactured or marketed. Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211 (drug labeler code 017033) requested that FDA withdraw approval of two ANADAs listed in table 2 because the products are no longer manufactured or marketed. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these actions.
Table 2—Applications for Which Approval Was Voluntarily Withdrawn During April, May, and June 2025
Date of withdrawal of approval
Application No.
Product name
21 CFR section
May 27, 2025
008-760
ADRENOMONE (corticotropin) Injectable Solution
522.480
Do
200-366
Carprofen Caplets (carprofen)
520.304
Do
200-575
Carprofen Chewable Tablets (carprofen)
520.304
III. Changes of Sponsor
The sponsor of the approved application listed in table 3 has informed FDA that they have transferred ownership of, and all rights and interest in, this application to another sponsor. The regulation cited in table 3 is amended to reflect this action.
Table 3—Applications for Which Ownership Was Transferred to Another Sponsor During April, May, and June 2025
Application No.
Product name
Transferring sponsor
(drug labeler code)
New sponsor
(drug labeler code)
21 CFR
section
200-512
TRIAMULOX (tiamulin hydrogen fumarate)
Zoetis Inc. (054771)
Phibro Animal Health Corp. (066104)
520.2455
IV. Change of Sponsor Address
Elanco US Inc., (drug labeler code 058198 in 21 CFR 510.600(c)) has informed FDA that it has changed its address. ECO LLC, (drug labeler code 066916 in 21 CFR 510.600(c)) also has informed FDA that it has changed its address. The entries in § 510.600(c) are amended to reflect these actions.
V. Technical Amendments
FDA is making the following amendments to improve the accuracy and readability of the animal drug regulations.
• 21 CFR 510.600(c) is amended to revise the entries for Elanco US Inc., and ECO, LLC in the lists of sponsors of approved applications, and to add entries for Genus plc. and Qilu Animal Health Products Co., Ltd.
• 21 CFR 510.600(c) is amended to change the name of “Sergeant's Pet Care Products, Inc.” to “Sergeant's Pet Care Products LLC” in the lists of sponsors of approved applications.
• 21 CFR 522.1260(e)(2)(iii) is amended to clarify that the statement “Federal law restricts this drug to use by or on the order of a licensed veterinarian” applies to all drug products in that paragraph.
VI. Legal Authority
This final rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.360b(i)). Although deemed a rule under the FD&C Act, this document does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a “rule of particular applicability” and is not subject to the congressional review requirements in 5 U.S.C. 801-808. Likewise, this is not a rule subject to Executive Order 12866.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 524, and 528
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 510, 520, 522, 524, 528, and 558 are amended as follows:
PART 510—NEW ANIMAL DRUGS
1. The authority citation for part 510 continues to read as follows:
Authority:
21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
2. In § 510.600:
a. In the table in paragraph (c)(1):
i. Revise the entries for “ECO LLC”, “Elanco US Inc.”;
ii. Add in alphabetical order entries for “Genus plc” and “Qilu Animal Health Products Co., Ltd.”; and
iii. Revise the entry for “Sergeant's Pet Care Products, Inc”;
b. In the table in paragraph (c)(2), add entries in numerical order for “086163” and “086205”; and revise the entries for “021091”; “058198”, and “066916”.
The revisions and additions read as follows:
§ 510.600
Names, addresses, and drug labeler codes of sponsors of approved applications.
(c) * * *
(1) * * *
Firm name and address
Drug labeler code
* * * * * * *
ECO LLC, 506 Carnegie Centre, Suite 400, Princeton, NJ 08540
066916
Elanco US Inc., 450 Elanco Circle, Indianapolis, IN 46221
058198
* * * * * * *
Genus plc, 1525 River Road, Deforest, WI 53532
086205
* * * * * * *
Qilu Animal Health Products Co., Ltd., No. 10688, Wenliang Road, Dongjia Town,
Licheng District Jinan, Shandong, 250100, China
086163
* * * * * * *
Sergeant's Pet Care Products LLC, 10077 S. 134th St., Omaha, NE 68138
021091
* * * * * * *
(2) * * *
Drug labeler code
Firm name and address
* * * * * * *
021091
Sergeant's Pet Care Products LLC, 10077 S. 134th St., Omaha, NE 68138
* * * * * * *
058198
Elanco US Inc., 450 Elanco Circle, Indianapolis, IN 46221
* * * * * * *
066916
ECO LLC, 506 Carnegie Centre, Suite 400, Princeton, NJ 08540
* * * * * * *
086163
Qilu Animal Health Products Co., Ltd., No. 10688, Wenliang Road, Dongjia Town, Licheng District Jinan, Shandong, 250100, China
* * * * * * *
086205
Genus plc, 1525 River Road, Deforest, WI 53532
* * * * * * *
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
3. The authority citation for part 520 continues to read as follows:
Authority:
21 U.S.C. 360b.
4. In § 520.35, revise paragraph (c)(2) by adding a sentence at the end of the paragraph to read as follows:
§ 520.35
Afoxolaner, moxidectin, and pyrantel.
(c) * * *
(2)
* * *
For the prevention of
Borrelia burgdorferi
infections as a direct result of killing
Ixodes scapularis
vector ticks.
§ 520.304
[Amended]
5. In § 520.304, in paragraph (b)(1), remove the text “Nos. 017033, 054771, 055529, and 082983” and in its place add the text “Nos. 054771, 055529, and 082983”.
§ 520.446
[Amended]
6. In § 520.446, in paragraph (b)(2), remove the text “No. 051311” and in its place add the text “Nos. 051311 and 086101”.
§ 520.812
[Amended]
7. In § 520.812, in paragraph (b)(2), remove the text “Nos. 017033 and 086117” and in its place add the text “Nos. 017033, 086117, and 086194”.
8. In § 520.1287, revise the first sentence in paragraph (c)(2) to read as follows:
§ 520.1287
Lotilaner, moxidectin, praziquantel, and pyrantel.
(c) * * *
(2)
Indications for use.
For the prevention of heartworm disease caused by
Dirofilaria immitis
and for the treatment and control of roundworm (immature adult and adult
Toxocara canis
and adult
Toxascaris leonina
), hookworm (fourth stage larvae, immature adult, and adult
Ancylostoma caninum
and adult
Uncinaria stenocephala
), and tapeworm (
Dipylidium caninum, Taenia
pisiformis,
and
Echinococcus granulosus
) infections. * * *
9. In § 520.1375, revise paragraph (b) and (c)(1) to read as follows:
§ 520.1375
Methimazole tablets.
(b)
Sponsors,
See Nos. 043264 and 086101in § 510.600 of this chapter.
(c) * * *
(1)
Amount.
The starting dose is 2.5 mg every 12 hours. Following 3 weeks of treatment, the dose should be titrated to effect based on individual serum total T4 (TT4) levels and clinical response. Dose adjustments should be made in 2.5 mg increments. The maximum total dosage is 20 mg per day divided, not to exceed 10 mg as a single administration.
10. In § 520.2090, revise paragraph (c)(2) to read as follows:
§ 520.2090
Sarolaner, moxidectin, and pyrantel.
(c) * * *
(2)
Indications for use.
For the prevention of heartworm disease caused by
Dirofilaria immitis
and for the treatment and control of roundworm (immature adult and adult
Toxocara canis
and adult
Toxascaris leonina
) and hookworm (L4, immature adult, and adult
Ancylostoma caninum
and adult
Uncinaria stenocephala
) infections. Kills adult fleas (
Ctenocephalides felis
) and is indicated for the treatment and prevention of flea infestations, the prevention of
Dipylidium caninum
(tapeworm) infections as a direct result of killing
Ctenocephalides felis
vector fleas on the treated dog, and the treatment and control of tick infestations with
Amblyomma americanum
(lone star tick),
Amblyomma maculatum
(Gulf Coast tick),
Dermacentor variabilis
(American dog tick),
Ixodes scapularis
(black-legged tick),
Rhipicephalus sanguineus
(brown dog tick), and
Haemaphysalis longicornis
(Asian longhorned tick) for one month in dogs and puppies 8 weeks of age and older, and weighing 2.8 pounds or greater. For the prevention of
Borrelia burgdorferi
infections as a direct result of killing
Ixodes scapularis
vector ticks.
11. In § 520.2455:
a. Revise paragraph (b)(2); and
b. Remove paragraph (b)(4).
The revision reads as follows:
§ 520.2455
Tiamulin.
(b) * * *
(2) No. 066104 for products described in paragraphs (a)(1) and (3) of this section.
(3) * * *
(c) * * *
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
12. The authority citation for part 522 continues to read as follows:
Authority:
21 U.S.C. 360b.
§ 522.311
[Amended]
13. In § 522.311, in paragraph (b), remove the text “
Sponsor.
See No. 054771 in § 510.600(c) of this chapter” and in its place add the text “
Sponsors.
See Nos. 054771 and 086163 in § 510.600(c) of this chapter”.
14. In § 522.480:
a. Revise paragraph (b); and
b. Remove paragraph (c)(3).
The revision reads as follows:
§ 522.480
Corticotropin.
(b)
Sponsor.
See No. 061133 in § 510.600(c) of this chapter.
(c)
Conditions of use
—
(1) * * *
(2) * * *
§ 522.970
[Amended]
15. In § 522.970, in paragraph (b)(1), remove the text “Nos. 000061, 055529, and 061133” and in its place add the text “Nos. 000061, 055529, 061133, and 069043”; and in paragraph (b)(3), remove the text “Nos. 016592, 058198, and 069043” and in its place add the text “Nos. 016592 and 058198”.
16. In § 522.1260, revise paragraph (e)(2)(iii) to read as follows:
§ 522.1260
Lincomycin.
(e) * * *
(2) * * *
(iii)
Limitations.
Do not treat within 48 hours of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
17. The authority citation for part 524 continues to read as follows:
Authority:
21 U.S.C360b.
18. In Part 524, add § 524.1144j to read as follows:
§ 524.1144j
Gentamicin, posaconazole, and mometasone furoate otic suspension.
(a)
Sponsor.
See No. 000061 in § 510.600(c) of this chapter
(b)
Specifications.
A 0.8 milliliters (mL) dose delivers 6.88 milligrams (mg) gentamicin, 2.08 mg posaconazole, and 1.68 mg mometasone furoate.
(c)
Conditions of use
—This product should be administered by a veterinary professional.
(1)
Amount.
The dose volume is 0.8 mL per affected ear. Verify the tympanic membrane is intact prior to administration.
(2)
Indications for use.
For the treatment of otitis externa associated with susceptible strains of yeast
(Malassezia pachydermatis)
and bacteria
(Staphylococcus pseudintermedius and Pseudomonas aeruginosa))
in dogs.
(3)
Limitations.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 524.1146
[Amended]
19. In § 524.1146, in paragraph (b)(2), remove the text “and 058198” and in its place add the text “058198, and 061133”; and in paragraph (b)(3), remove the text “058198, and” and in its place add the text “058198, 061133, and”.
20. Add § 524.1312 to read as follows:
§ 524.1312
Marbofloxacin, terbinafine, and dexamethasone otic suspension.
(a)
Specifications.
Each single-use tube contains 15.1 milligrams (mg) marbofloxacin, 22.7 mg terbinafine, and 2.01 mg dexamethasone.
(b)
Sponsor.
See No. 043264 in § 510.600(c) of this chapter.
(c)
Conditions of use
—(1)
Amount.
Administer one dose (1 tube) per affected ear once. Do not clean the ear canal for 30 days after administration.
(2)
Indications for use.
For the treatment of otitis externa associated with susceptible strains of yeast
(Malassezia pachydermatis)
and bacteria
(Staphylococcus pseudintermedius)
in dogs.
(3)
Limitations.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
PART 528—INTENTIONAL GENOMIC ALTERATIONS IN ANIMALS
21. The authority citation for part 528 continues to read as follows:
Authority:
21 U.S.C. 360b.
22. Add § 528.2000 to read as follows:
§ 528.2000
Deletion of exon 7 of CD163 gene in domestic pigs.
(a)
Specifications.
Deletion of one (heterozygous) or two (homozygous) copies of exon 7 of
CD163
gene1(abbreviated CD163ΔE7) in domestic pigs (
Sus scrofa domesticus
).
(b)
Sponsor.
See No. 086205 in § 510.600(c) of this chapter.
(c)
Conditions of use
—(1)
Intended use.
Deletion of exon 7 of the
CD163
gene in domestic pigs (
Sus scrofa domesticus)
is intended to confer resistance to porcine reproductive and respiratory syndrome virus (PRRSV) in homozygous pigs. Pigs carrying one or two copies of CD163
D
E7
, and their offspring, are intended for breeding or to be used as sources of food.
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
23. The authority citation for part 558 continues to read as follows:
Authority:
21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
24. In § 558.68, revise paragraphs (e)(1)(ii) and (vii) to read as follows:
§ 558.68
Avilamycin.
(e) * * *
(1) * * *
Avilamycin in grams/ton
Combination in
grams/ton
Indications for use
Limitations
Sponsor
* * * * * * *
(ii) 13.6 to 40.9
Monensin, 90 to 110
Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with
Clostridium perfringens,
and as an aid in the prevention of coccidiosis caused by E
imeria necatrix, E. tenella,
E. acervulina, E. brunetti,
E. mivati,
and
E. maxima
Feed as the sole ration for 21 consecutive days. Feed to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with
Clostridium perfringens.
To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. Monensin as provided by Nos. 016592 or 058198 in § 510.600(c) of this chapter. See § 558.355(d)
016592
058198
* * * * * * *
* * * * * * *
(vii) 100
For the treatment of swine dysentery and the control of porcine proliferative enteropathies (ileitis) caused by
Lawsonia intracellularis
Feed as a sole ration for 3 weeks or until signs of disease (watery, mucoid, or bloody stools) disappear
066104
* * * * * * *
25. In § 558.355, revise paragraphs (b)(2), (e)(1)(vii) and (xiv), and (e)(2)(ii) through (v) to read as follows:
§ 558.355
Monensin.
(b) * * *
(2) No. 016592 for use of a Type A medicated article containing 90.7 grams monensin, USP, per pound as in paragraphs (e)(1)(i), (e)(1)(ii), (e)(1)(vii), (e)(1)(xiv), (e)(2), (e)(3), (e)(4)(v), and (e)(5) of this section.
(e) * * *
(1) * * *
Monensin in grams/ton
Combination in
grams/ton
Indications for use
Limitations
Sponsor
* * * * * * *
(vii) 90 to 110
Bacitracin methylenedisalicylate, 5 to 25
Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella,
E. acervulina, E. brunetti,
E. mivati,
and
E. maxima,
and for increase in rate of weight gain and improved feed efficiency
Feed as the sole ration. Monensin as provided by Nos. 016592 or 058198; bacitracin methylenedisalicylate as provided by No. 066104 in § 510.600(c) of this chapter. See special labeling considerations in paragraph (d) of this section.
016592
058198
* * * * * * *
(xiv) 90 to 110
Bambermycins, 1 to 2
Broiler chickens: As an aid in the prevention of coccidiosis caused by
Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati,
and
E. maxima,
and for increase in rate of weight gain and improved feed efficiency
Feed as the sole ration. Monensin as provided by Nos. 016592 or 058198; bambermycins as provided by No. 016592 in § 510.600(c) of this chapter. See special labeling considerations in paragraph (d) of this section.
016592
058198
* * * * * * *
(2) * * *
Monensin in grams/ton
Combination in
grams/ton
Indications for use
Limitations
Sponsor
* * * * * * *
(ii) 54 to 90
Bacitracin methylenedisalicylate, 4 to 50
Growing turkeys: For the prevention of coccidiosis caused by
Eimeria adenoeides, E. meleagrimitis,
and
E. gallopavonis,
and for increased rate of weight gain and improved feed efficiency
Feed continuously as the sole ration. The optimum level depends upon the severity of coccidiosis exposure. Monensin as provided by Nos. 016592 or 058198; bacitracin methylenedisalicylate as provided by Nos. 066104 or 069254 in § 510.600(c) of this chapter. See special labeling considerations in paragraph (d) of this section
016592
058198
069254
(iii) 54 to 90
Bacitracin methylenedisalicycate, 200
Growing turkeys: For the prevention of coccidiosis caused by
Eimeria adenoeides, E. meleagrimitis,
and
E. gallopavonis,
and as an aid in the control of transmissible enteritis complicated by organisms susceptible to bacitracin methylenedisalicylate
Feed continuously as the sole ration. Monensin as provided by Nos. 016592 or 058198; bacitracin methylenedisalicylate as provided by No. 066104 in § 510.600(c)
of this chapter.
See special labeling considerations in paragraph (d) of this section
016592
058198
(iv) 54 to 90
Bambermycins, 1 to 2
Growing turkeys: For the prevention of coccidiosis caused by
Eimeria adenoeides, E. meleagrimitis,
and
E. gallopavonis,
and for improved feed efficiency
Feed continuously as the sole ration. Monensin as provided by Nos. 016592 or 058198; bambermycins as provided by No. 016592 in § 510.600(c) of this chapter. See special labeling considerations in paragraph (d) of this section
016592
058198
(v) 54 to 90
Bambermycins, 2
Growing turkeys: For the prevention of coccidiosis caused by
Eimeria adenoeides, E. meleagrimitis,
and
E. gallopavonis,
and for increased rate of weight gain and improved feed efficiency
Feed continuously as sole ration. Monensin as provided by Nos. 016592 or 058198; bambermycins as provided by No. 016592 in § 510.600(c) of this chapter. See special labeling considerations in paragraph (d) of this section
016592
058198
26. In § 558.635, add paragraphs (e)(3)(ii) through (viii) to read as follows:
§ 558.635
Virginiamycin.
(e) * * *
(3) * * *
Virginiamycin grams/ton
Combination in
grams/ton
Indications for use
Limitations
Sponsor
* * * * * * *
(ii) 13.5 to 16.0
Monensin, 5 to 40
Growing beef steers and heifers fed in confinement for slaughter: For improved feed efficiency and reduction of incidence of liver abscesses
Feed at every feeding to provide 50 to 480 mg monensin/head/day and 85 to 240 mg virginiamycin/head/day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 g/ton (360 mg monensin/head/day). A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. See § 558.355(d)
066104
(iii) 13.5 to 16.0
Monensin, 10 to 40
Growing beef steers and heifers fed in confinement for slaughter: For the prevention and control of coccidiosis caused by
Eimeria bovis
and
Eimeria zuernii,
and reduction of incidence of liver abscesses
Feed at every feeding to provide 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of coccidiosis challenge, up to a maximum of 480 mg monensin/head/day and 85 to 240 mg virginiamycin/head/day. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. See § 558.355(d)
066104
(iv) 13.5 to 16.0
Monensin, 5 to 40; and lubabegron, 1.25 to 4.54
Growing beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed: For reduction of ammonia gas emissions per pound of live weight and hot carcass weight, improved feed efficiency, and reduction of incidence of liver abscesses
Feed at every feeding as sole ration to provide 13 to 90 mg lubabegron/head/day, 50 to 480 mg monensin/head/day and 85 to 240 mg virginiamycin/head/day during the last 14 to 91 days on feed. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 g/ton (360 mg monensin/head/day). A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. See § 558.355(d)
066104
(v) 13.5 to 16.0
Monensin, 10 to 40; and lubabegron, 1.25 to 4.54
Growing beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed: For reduction of ammonia gas emissions per pound of live weight and hot carcass weight, the prevention and control of coccidiosis caused by
Eimeria bovis
and
Eimeria zuernii,
and reduction of incidence of liver abscesses
Feed at every feeding as sole ration to provide 13 to 90 mg lubabegron/head/day, 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of coccidiosis challenge, up to a maximum of 480 mg monensin/head/day and 85 to 240 mg virginiamycin/head/day during the last 14 to 91 days on feed. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. See § 558.355(d)
066104
(vi) 13.5 to 16.0
Monensin, 10 to 40; and ractopamine hydrochloride, 8.2 to 24.6
Growing beef steers and heifers fed in confinement for slaughter during the last 28 to 42 days on feed: For increased rate of weight gain, improved feed efficiency, the prevention and control of coccidiosis caused by
Eimeria bovis
and
Eimeria zuernii,
and reduction of incidence of liver abscesses
Feed at every feeding as a sole ration to provide 70 to 430 mg ractopamine hydrochloride/head/day, 0.14 to 0.42 mg monensin/lb of body weight per day, depending upon severity of coccidiosis challenge, up to a maximum of 480 mg monensin/head/day and 85 to 240 mg virginiamycin/head/day during the last 28 to 42 days on feed. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. See § 558.355(d)
066104
(vii) 13.5 to 6.0
Monensin, 10 to 40; and ractopamine hydrochloride, 9.8 to 24.6
Growing beef steers and heifers fed in confinement for slaughter during the last 28 to 42 days on feed: For increased rate of weight gain, improved feed efficiency, increased carcass leanness, the prevention and control of coccidiosis caused by
Eimeria bovis
and
Eimeria zuernii,
and reduction of incidence of liver abscesses
Feed at every feeding as a sole ration to provide 90 to 430 mg ractopamine hydrochloride/head/day, 0.14 to 0.42 mg monensin/lb of body weight per day, depending upon severity of coccidiosis challenge, up to a maximum of 480 mg monensin/head/day and 85 to 240 mg virginiamycin/head/day during the last 28 to 42 days on feed. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. See § 558.355(d)
066104
(viii) 13.5 to 16.0
Monensin, 10 to 40; and ractopamine hydrochloride, not to exceed 800
Growing beef steers and heifers fed in confinement for slaughter during the last 28 to 42 days on feed: For increased rate of weight gain and improved feed efficiency, the prevention and control of coccidiosis caused by
Eimeria bovis
and
Eimeria zuernii,
and reduction of incidence of liver abscesses when ractopamine hydrochloride is used as a top dress with rations containing monensin and virginiamycin
Feed a minimum of 1.0 lb per head per day of this Type C top-dress medicated feed to provide 70 to 400 mg/head/day ractopamine hydrochloride during the last 28 to 42 days on feed. Must be top dressed onto or mixed at feeding with a Type C medicated feed containing 10 to 40 g/ton monensin and 13.5 to 16 g/ton virginiamycin (90% dry matter basis), to provide 0.14 to 0.42 mg monensin/lb of body weight per day, depending upon severity of coccidiosis challenge, up to a maximum of 480 mg monensin/head/day and 85 to 240 mg virginiamycin/head/day. See § 558.355(d)
066104
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-16079 Filed 8-21-25; 8:45 am]
BILLING CODE 4164-01-P
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