Rule2025-16079
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 22, 2025
Effective
August 22, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 90 Issue 161 (Friday, August 22, 2025)</title>
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[Federal Register Volume 90, Number 161 (Friday, August 22, 2025)]
[Rules and Regulations]
[Pages 40966-40973]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-16079]
=======================================================================
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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, <a href="/cdn-cgi/l/email-protection#472426332f2e22692a2635342f262b2b07212326692f2f3469202831"><span class="__cf_email__" data-cfemail="640705100c0d014a090516170c050808240200054a0c0c174a030b12">[email protected]</span></a>.
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: <a href="https://animaldrugsatfda.fda.gov/adafda/views/#/search">https://animaldrugsatfda.fda.gov/adafda/views/#/search</a>.
Table 1--Original And Supplemental Applications Approved During April, May, and June 2025
----------------------------------------------------------------------------------------------------------------
Application Sponsor (drug Effect of the 21 CFR
Date of approval No. labeler code \1\) Product name action sections
----------------------------------------------------------------------------------------------------------------
March 24, 2025 \2\......... 200-811 Bimeda Animal MOXICLOPRID for Original approval 524.1146
Health Ltd. Cats as a generic
(061133). (imidacloprid copy of NADA
and moxidectin) 141[dash]254.
Topical Solution.
[[Page 40967]]
March 24, 2025 \3\......... 200-810 Hikma Enrofloxacin Original approval 520.812
Pharmaceuticals Flavored Tablets as a generic ..........
USA, Inc. (enrofloxacin copy of NADA
(086194). flavored 140[dash]441.
tablets).
April 3, 2025.............. 200-791 Cronus FLUNINE-S Original approval 522.970
Pharmaceuticals (flunixin as a generic
Specialities meglumine copy of NADA
India Private injection) 101[dash]479.
Ltd. (069043). Injectable
Solution.
April 7, 2025.............. 141-586 Phibro Animal V-MAX Original approval 558.635
Health Corp. (virginiamycin),
(066104). RUMENSIN
(monensin), and
EXPERIOR
(lubabegron)
Type A medicated
articles to be
used in the
manufacture of
Type B and Type
C medicated
cattle feed.
April 7, 2025.............. 141-588 Phibro Animal V-MAX Original approval 558.635
Health Corp. (virginiamycin)
(066104). and RUMENSIN
(monensin) Type
A medicated
articles to be
used in the
manufacture of
Type B/C
medicated cattle
feeds.
April 8, 2025.............. 141-587 Phibro Animal V-MAX Original approval 558.635
Health Corp. (virginiamycin),
(066104). RUMENSIN
(monensin), and
OPTAFLEXX
(ractopamine
hydrochloride)
Type A medicated
articles to be
used in the
manufacture of
Type B/C
medicated cattle
feeds.
April 8, 2025.............. 141-521 Zoetis Inc SIMPARICA TRIO Supplemental 520.2090
(054771). (sarolaner, approval.
moxidectin, and
pyrantel
chewable
tablets)
Chewable Tablets.
April 10, 2025............. 141-598 Dechra Ltd. OTISERENE Original approval 524.1312
(043264). (marbofloxacin
terbinafine
dexamethasone
otic suspension).
April 23, 2025............. 141-554 Boehringer NEXGARD PLUS Supplemental 520.35
Ingelheim Animal (afoxolaner, approval.
Health USA, moxidectin, and
Inc.(000010). pyrantel
chewable
tablets).
April 24, 2025............. 200-797 Huvepharma EOOD.. COXIDIN Original approval 558.355
(016592)......... (monensin) and as a generic
BMD (bacitracin copy of NADA 049-
methylenedisalic 463.
ylate) Type A
medicated
articles to be
used in the
manufacture of
Type C medicated
broiler feeds.
April 24, 2025............. 200-798 Huvepharma EOOD COXIDIN Original approval 558.355
(016592). (monensin) and as a generic
FLAVOMYCIN copy of NADA
(bambermycins) 098[dash]340.
Type A medicated
articles to be
used in the
manufacture of
Type C medicated
broiler feeds.
April 24, 2025............. 200-799 Huvepharma EOOD COXIDIN Original approval 558.355
(016592). (monensin) and as a generic
BMD (bacitracin copy of NADA
methylenedisalic 140[dash]937.
ylate) Type A
medicated
articles to be
used in the
manufacture of
Type C medicated
turkey feeds.
April 24, 2025............. 200-800 Huvepharma EOOD COXIDIN Original approval 558.355
(016592). (monensin) and as a generic
FLAVOMYCIN copy of NADA
(bambermycins) 140[dash]955.
Type A medicated
articles to be
used in the
manufacture of
Type C medicated
turkey feeds.
April 24, 2025............. 200-801 Huvepharma EOOD COXIDIN Original approval 558.68
(016592). (monensin) and as a generic
INTEPRITY copy of NADA
(avilamycin) 141[dash]465.
Type A medicated
articles to be
used in the
manufacture of
Type C medicated
broiler feeds.
April 24, 2025............. 200-802 Huvepharma EOOD COXIDIN Original approval 558.355
(016592). (monensin) and as a generic
PENNITRACIN MD copy of NADA
(bacitracin 141[dash]540.
methylenedisalic
ylate) Type A
medicated
articles to be
used in the
manufacture of
Type C medicated
turkey feeds.
April 29, 2025............. 141-609 Genus plc DELETION OF EXON Original approval 528.2000
(086205). 7 OF CD163 GENE
IN DOMESTIC PIGS
(Deletion of
exon 7 of CD163
gene in domestic
pigs).
April 29, 2025............. 141-600 Intervet (000061) MOMETAMAX SINGLE Original approval 524.1044j
(gentamicin,
posaconazole,
and mometasone
furoate otic
suspension).
May 21, 2025............... 141-581 Elanco US Inc. CREDELIO QUATTRO Supplemental 520.1287
(058198). (lotilaner, approval.
moxidectin,
praziquantel,
and pyrantel).
June 24, 2025.............. 200-812 Qilu Animal Cefovecin Sodium Original approval 522.311
Health Products for Injection as a generic
Co., Ltd. (cefovecin copy of NADA 141-
(086163). sodium). 285.
[[Page 40968]]
June 27, 2025.............. 200-813 Felix Clindamycin Original approval 520.446
Pharmaceuticals Hydrochloride as a generic
Pvt. Ltd. Tablets copy of NADA 120-
(086101). (clindamycin 161.
hydrochloride).
June 27, 2025.............. 200-814 Felix Methimazole Original approval 520.1375
Pharmaceuticals Coated Tablets as a generic
Pvt. Ltd. (methimazole copy of NADA 141-
(086101). tablets). 292.
----------------------------------------------------------------------------------------------------------------
\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 Application 21 CFR
approval No. Product name section
------------------------------------------------------------------------
May 27, 2025.............. 008-760 ADRENOMONE 522.480
(corticotropin)
Injectable
Solution.
Do........................ 200-366 Carprofen 520.304
Caplets
(carprofen).
Do........................ 200-575 Carprofen 520.304
Chewable
Tablets
(carprofen).
------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Transferring sponsor New sponsor (drug 21 CFR
Application No. Product name (drug labeler code) labeler code) section
----------------------------------------------------------------------------------------------------------------
200-512........................ TRIAMULOX (tiamulin Zoetis Inc. (054771). Phibro Animal Health 520.2455
hydrogen fumarate). Corp. (066104).
----------------------------------------------------------------------------------------------------------------
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 Sec. 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.
<bullet> 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.
<bullet> 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.
<bullet> 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
0
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.
0
2. In Sec. 510.600:
0
a. In the table in paragraph (c)(1):
0
i. Revise the entries for ``ECO LLC'', ``Elanco US Inc.'';
[[Page 40969]]
0
ii. Add in alphabetical order entries for ``Genus plc'' and ``Qilu
Animal Health Products Co., Ltd.''; and
0
iii. Revise the entry for ``Sergeant's Pet Care Products, Inc'';
0
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:
Sec. 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, 066916
Princeton, NJ 08540..............................
Elanco US Inc., 450 Elanco Circle, Indianapolis, 058198
IN 46221.........................................
* * * * * * *
Genus plc, 1525 River Road, Deforest, WI 53532.... 086205
* * * * * * *
Qilu Animal Health Products Co., Ltd., No. 10688, 086163
Wenliang Road, Dongjia Town,.....................
Licheng District Jinan, Shandong, 250100, China...
* * * * * * *
Sergeant's Pet Care Products LLC, 10077 S. 134th 021091
St., Omaha, NE 68138.............................
* * * * * * *
------------------------------------------------------------------------
(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
0
3. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
4. In Sec. 520.35, revise paragraph (c)(2) by adding a sentence at the
end of the paragraph to read as follows:
Sec. 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.
* * * * *
Sec. 520.304 [Amended]
0
5. In Sec. 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''.
Sec. 520.446 [Amended]
0
6. In Sec. 520.446, in paragraph (b)(2), remove the text ``No.
051311'' and in its place add the text ``Nos. 051311 and 086101''.
Sec. 520.812 [Amended]
0
7. In Sec. 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''.
0
8. In Sec. 520.1287, revise the first sentence in paragraph (c)(2) to
read as follows:
Sec. 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
[[Page 40970]]
pisiformis, and Echinococcus granulosus) infections. * * *
* * * * *
0
9. In Sec. 520.1375, revise paragraph (b) and (c)(1) to read as
follows:
Sec. 520.1375 Methimazole tablets.
* * * * *
(b) Sponsors, See Nos. 043264 and 086101in Sec. 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.
* * * * *
0
10. In Sec. 520.2090, revise paragraph (c)(2) to read as follows:
Sec. 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.
* * * * *
0
11. In Sec. 520.2455:
0
a. Revise paragraph (b)(2); and
0
b. Remove paragraph (b)(4).
The revision reads as follows:
Sec. 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
0
12. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 522.311 [Amended]
0
13. In Sec. 522.311, in paragraph (b), remove the text ``Sponsor. See
No. 054771 in Sec. 510.600(c) of this chapter'' and in its place add
the text ``Sponsors. See Nos. 054771 and 086163 in Sec. 510.600(c) of
this chapter''.
0
14. In Sec. 522.480:
0
a. Revise paragraph (b); and
0
b. Remove paragraph (c)(3).
The revision reads as follows:
Sec. 522.480 Corticotropin.
* * * * *
(b) Sponsor. See No. 061133 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--
(1) * * *
(2) * * *
Sec. 522.970 [Amended]
0
15. In Sec. 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''.
0
16. In Sec. 522.1260, revise paragraph (e)(2)(iii) to read as follows:
Sec. 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
0
17. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C360b.
0
18. In Part 524, add Sec. 524.1144j to read as follows:
Sec. 524.1144j Gentamicin, posaconazole, and mometasone furoate otic
suspension.
(a) Sponsor. See No. 000061 in Sec. 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.
Sec. 524.1146 [Amended]
0
19. In Sec. 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''.
0
20. Add Sec. 524.1312 to read as follows:
Sec. 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 Sec. 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
0
21. The authority citation for part 528 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
22. Add Sec. 528.2000 to read as follows:
Sec. 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
CD163[Delta]E7) in domestic pigs (Sus scrofa domesticus).
[[Page 40971]]
(b) Sponsor. See No. 086205 in Sec. 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
CD163D<SUP>E7</SUP>, 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
0
23. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
24. In Sec. 558.68, revise paragraphs (e)(1)(ii) and (vii) to read as
follows:
Sec. 558.68 Avilamycin.
* * * * *
(e) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Combination in
Avilamycin in grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(ii) 13.6 to 40.9.............. Monensin, 90 to Broiler chickens: For Feed as the sole ration 016592
110. the prevention of for 21 consecutive 058198
mortality caused by days. Feed to chickens
necrotic enteritis that are at risk of
associated with developing, but not
Clostridium yet showing clinical
perfringens, and as an signs of, necrotic
aid in the prevention enteritis associated
of coccidiosis caused with Clostridium
by Eimeria necatrix, perfringens. To assure
E. tenella, E. responsible
acervulina, E. antimicrobial drug use
brunetti, E. mivati, in broiler chickens,
and E. maxima. treatment
administration must
begin on or before 18
days of age. Monensin
as provided by Nos.
016592 or 058198 in
Sec. 510.600(c) of
this chapter. See Sec.
558.355(d).
* * * * * * *
* * * * * * *
(vii) 100...................... .................. For the treatment of Feed as a sole ration 066104
swine dysentery and for 3 weeks or until
the control of porcine signs of disease
proliferative (watery, mucoid, or
enteropathies bloody stools)
(ileitis) caused by disappear.
Lawsonia
intracellularis.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
0
25. In Sec. 558.355, revise paragraphs (b)(2), (e)(1)(vii) and (xiv),
and (e)(2)(ii) through (v) to read as follows:
Sec. 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) * * *
----------------------------------------------------------------------------------------------------------------
Combination in
Monensin in grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(vii) 90 to 110................ Bacitracin Broiler chickens: As an Feed as the sole 016592
methylenedisalicy aid in the prevention ration. Monensin as 058198
late, 5 to 25. of coccidiosis caused provided by Nos.
by Eimeria necatrix, 016592 or 058198;
E. tenella, E. bacitracin
acervulina, E. methylenedisalicylate
brunetti, E. mivati, as provided by No.
and E. maxima, and for 066104 in Sec.
increase in rate of 510.600(c) of this
weight gain and chapter. See special
improved feed labeling
efficiency. considerations in
paragraph (d) of this
section..
* * * * * * *
(xiv) 90 to 110................ Bambermycins, 1 to Broiler chickens: As an Feed as the sole 016592
2. aid in the prevention ration. Monensin as 058198
of coccidiosis caused provided by Nos.
by Eimeria necatrix, 016592 or 058198;
E. tenella, E. bambermycins as
acervulina, E. provided by No. 016592
brunetti, E. mivati, in Sec. 510.600(c)
and E. maxima, and for of this chapter. See
increase in rate of special labeling
weight gain and considerations in
improved feed paragraph (d) of this
efficiency. section..
* * * * * * *
----------------------------------------------------------------------------------------------------------------
(2) * * *
[[Page 40972]]
----------------------------------------------------------------------------------------------------------------
Combination in
Monensin in grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(ii) 54 to 90.................. Bacitracin Growing turkeys: For Feed continuously as 016592
methylenedisalicy the prevention of the sole ration. The 058198
late, 4 to 50. coccidiosis caused by optimum level depends 069254
Eimeria adenoeides, E. upon the severity of
meleagrimitis, and E. coccidiosis exposure.
gallopavonis, and for Monensin as provided
increased rate of by Nos. 016592 or
weight gain and 058198; bacitracin
improved feed methylenedisalicylate
efficiency. as provided by Nos.
066104 or 069254 in
Sec. 510.600(c) of
this chapter. See
special labeling
considerations in
paragraph (d) of this
section.
(iii) 54 to 90................. Bacitracin Growing turkeys: For Feed continuously as 016592
methylenedisalicy the prevention of the sole ration. 058198
cate, 200. coccidiosis caused by Monensin as provided
Eimeria adenoeides, E. by Nos. 016592 or
meleagrimitis, and E. 058198; bacitracin
gallopavonis, and as methylenedisalicylate
an aid in the control as provided by No.
of transmissible 066104 in Sec.
enteritis complicated 510.600(c) of this
by organisms chapter. See special
susceptible to labeling
bacitracin considerations in
methylenedisalicylate. paragraph (d) of this
section.
(iv) 54 to 90.................. Bambermycins, 1 to Growing turkeys: For Feed continuously as 016592
2. the prevention of the sole ration. 058198
coccidiosis caused by Monensin as provided
Eimeria adenoeides, E. by Nos. 016592 or
meleagrimitis, and E. 058198; bambermycins
gallopavonis, and for as provided by No.
improved feed 016592 in Sec.
efficiency. 510.600(c) of this
chapter. See special
labeling
considerations in
paragraph (d) of this
section.
(v) 54 to 90................... Bambermycins, 2... Growing turkeys: For Feed continuously as 016592
the prevention of sole ration. Monensin 058198
coccidiosis caused by as provided by Nos.
Eimeria adenoeides, E. 016592 or 058198;
meleagrimitis, and E. bambermycins as
gallopavonis, and for provided by No. 016592
increased rate of in Sec. 510.600(c)
weight gain and of this chapter. See
improved feed special labeling
efficiency. considerations in
paragraph (d) of this
section.
----------------------------------------------------------------------------------------------------------------
* * * * *
0
26. In Sec. 558.635, add paragraphs (e)(3)(ii) through (viii) to read
as follows:
Sec. 558.635 Virginiamycin.
* * * * *
(e) * * *
(3) * * *
----------------------------------------------------------------------------------------------------------------
Combination in
Virginiamycin grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(ii) 13.5 to 16.0.............. Monensin, 5 to 40. Growing beef steers and Feed at every feeding 066104
heifers fed in to provide 50 to 480
confinement for mg monensin/head/day
slaughter: For and 85 to 240 mg
improved feed virginiamycin/head/
efficiency and day. No additional
reduction of incidence improvement in feed
of liver abscesses. 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 Sec.
558.355(d).
(iii) 13.5 to 16.0............. Monensin, 10 to 40 Growing beef steers and Feed at every feeding 066104
heifers fed in to provide 0.14 to
confinement for 0.42 mg monensin/lb
slaughter: For the body weight per day,
prevention and control depending on the
of coccidiosis caused severity of
by Eimeria bovis and coccidiosis challenge,
Eimeria zuernii, and up to a maximum of 480
reduction of incidence mg monensin/head/day
of liver abscesses. 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 Sec.
558.355(d).
(iv) 13.5 to 16.0.............. Monensin, 5 to 40; Growing beef steers and Feed at every feeding 066104
and lubabegron, heifers fed in as sole ration to
1.25 to 4.54. confinement for provide 13 to 90 mg
slaughter during the lubabegron/head/day,
last 14 to 91 days on 50 to 480 mg monensin/
feed: For reduction of head/day and 85 to 240
ammonia gas emissions mg virginiamycin/head/
per pound of live day during the last 14
weight and hot carcass to 91 days on feed. No
weight, improved feed additional improvement
efficiency, and in feed efficiency has
reduction of incidence been shown from
of liver abscesses. 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 Sec.
558.355(d).
[[Page 40973]]
(v) 13.5 to 16.0............... Monensin, 10 to Growing beef steers and Feed at every feeding 066104
40; and heifers fed in as sole ration to
lubabegron, 1.25 confinement for provide 13 to 90 mg
to 4.54. slaughter during the lubabegron/head/day,
last 14 to 91 days on 0.14 to 0.42 mg
feed: For reduction of monensin/lb body
ammonia gas emissions weight per day,
per pound of live depending on the
weight and hot carcass severity of
weight, the prevention coccidiosis challenge,
and control of up to a maximum of 480
coccidiosis caused by mg monensin/head/day
Eimeria bovis and and 85 to 240 mg
Eimeria zuernii, and virginiamycin/head/day
reduction of incidence during the last 14 to
of liver abscesses. 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 Sec.
558.355(d).
(vi) 13.5 to 16.0.............. Monensin, 10 to Growing beef steers and Feed at every feeding 066104
40; and heifers fed in as a sole ration to
ractopamine confinement for provide 70 to 430 mg
hydrochloride, slaughter during the ractopamine
8.2 to 24.6. last 28 to 42 days on hydrochloride/head/
feed: For increased day, 0.14 to 0.42 mg
rate of weight gain, monensin/lb of body
improved feed weight per day,
efficiency, the depending upon
prevention and control severity of
of coccidiosis caused coccidiosis challenge,
by Eimeria bovis and up to a maximum of 480
Eimeria zuernii, and mg monensin/head/day
reduction of incidence and 85 to 240 mg
of liver abscesses. 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 Sec.
558.355(d).
(vii) 13.5 to 6.0.............. Monensin, 10 to Growing beef steers and Feed at every feeding 066104
40; and heifers fed in as a sole ration to
ractopamine confinement for provide 90 to 430 mg
hydrochloride, slaughter during the ractopamine
9.8 to 24.6. last 28 to 42 days on hydrochloride/head/
feed: For increased day, 0.14 to 0.42 mg
rate of weight gain, monensin/lb of body
improved feed weight per day,
efficiency, increased depending upon
carcass leanness, the severity of
prevention and control coccidiosis challenge,
of coccidiosis caused up to a maximum of 480
by Eimeria bovis and mg monensin/head/day
Eimeria zuernii, and and 85 to 240 mg
reduction of incidence virginiamycin/head/day
of liver abscesses. 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 Sec.
558.355(d).
(viii) 13.5 to 16.0............ Monensin, 10 to Growing beef steers and Feed a minimum of 1.0 066104
40; and heifers fed in lb per head per day of
ractopamine confinement for this Type C top-dress
hydrochloride, slaughter during the medicated feed to
not to exceed 800. last 28 to 42 days on provide 70 to 400 mg/
feed: For increased head/day ractopamine
rate of weight gain hydrochloride during
and improved feed the last 28 to 42 days
efficiency, the on feed. Must be top
prevention and control dressed onto or mixed
of coccidiosis caused at feeding with a Type
by Eimeria bovis and C medicated feed
Eimeria zuernii, and containing 10 to 40 g/
reduction of incidence ton monensin and 13.5
of liver abscesses to 16 g/ton
when ractopamine virginiamycin (90% dry
hydrochloride is used matter basis), to
as a top dress with provide 0.14 to 0.42
rations containing mg monensin/lb of body
monensin and weight per day,
virginiamycin. 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 Sec.
558.355(d).
----------------------------------------------------------------------------------------------------------------
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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