Rule2026-02331

New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address

Primary source

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Published
February 6, 2026
Effective
February 6, 2026

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), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during July, August, and September 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 91 Issue 25 (Friday, February 6, 2026)</title>
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[Federal Register Volume 91, Number 25 (Friday, February 6, 2026)]
[Rules and Regulations]
[Pages 5299-5303]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-02331]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 516, 520, 522, 529, 556, and 558

[Docket No. FDA-2025-N-0002]


New Animal Drugs; Approval of New Animal Drug Applications; 
Withdrawal of Approval of New Animal Drug Application; 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), abbreviated new animal drug 
applications (ANADAs), and conditionally approved new animal drug 
applications (CNADAs) during July, August, and September 2025. The 
animal drug regulations are also being amended to improve their 
accuracy and readability.

DATES: This rule is effective February 6, 2026.

FOR FURTHER INFORMATION CONTACT: Cathie Marshall, Center for Veterinary 
Medicine, Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740, <a href="/cdn-cgi/l/email-protection#a2c1c3d6cacbc78ccfc3d0d1cac3cecee2c4c6c38ccacad18cc5cdd4"><span class="__cf_email__" data-cfemail="325153465a5b571c5f5340415a535e5e725456531c5a5a411c555d44">[email&#160;protected]</span></a>, 240-402-5693.

SUPPLEMENTARY INFORMATION:

I. Approval of Applications

    FDA is amending the animal drug regulations to reflect approval 
actions for NADAs, ANADAs, and CNADAs during July, August, and 
September 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, Conditional, and Supplemental Applications Approved During July, August, and September 2025
----------------------------------------------------------------------------------------------------------------
                              Application    Sponsor  (drug                           Effect of the      21 CFR
      Date of approval            No.       labeler code \1\)     Product name           action         sections
----------------------------------------------------------------------------------------------------------------
July 8, 2025...............       200-807  Huvepharma EOOD     MGA (melengestrol   Original approval     558.330
                                            (016592).           acetate Type A      as a generic copy
                                                                medicated           of NADA 141-590.
                                                                article) and
                                                                EXPERIOR
                                                                (lubabegron Type
                                                                A medicated
                                                                article) and
                                                                MONOVET (monensin
                                                                Type A medicated
                                                                article).
July 8, 2025...............       200-808  Huvepharma EOOD     MGA (melengestrol   Original approval     558.625
                                            (016592).           acetate Type A      as a generic copy
                                                                medicated           of NADA 141-591.
                                                                article) and
                                                                EXPERIOR
                                                                (lubabegron Type
                                                                A medicated
                                                                article) and
                                                                MONOVET (monensin
                                                                Type A medicated
                                                                article) and
                                                                TYLOVET (tylosin
                                                                phosphate Type A
                                                                medicated
                                                                article).
July 8, 2025...............       200-815  Felix               Cefpodoxime         Original approval     520.370
                                            Pharmaceuticals     Proxetil Tablets    as a generic copy
                                            Pvt. Ltd.           (cefpodoxime        of NADA 141-232.
                                            (086101).           proxetil tablets).
July 10, 2025..............       141-599  Intervet, Inc.      BRAVECTO QUANTUM    Original approval.    522.998
                                            (000061).           (fluralaner for
                                                                extended-release
                                                                injectable
                                                                suspension).
July 11, 2025..............       200-816  Cronus Pharma       Meloxisol           Original approval    520.1367
                                            Specialities        (meloxicam oral     as a generic copy
                                            India Private       suspension 1.5 mg/  of NADA 141-213.
                                            Ltd. (069043).      mL).
July 17, 2025..............       141-607  Intervet, Inc.      EXZOLT (fluralaner  Original approval.    520.999
                                            (000061).           oral solution).                          556.290
July 18, 2025..............       200-759  ZyVet Animal        Furosemide Tablets  Original approval    520.1010
                                            Health, Inc.        (furosemide         as a generic copy
                                            (086117).           tablets).           of NADA 034-621.
July 21, 2025..............       200-817  Felix               Meloxicam Oral      Original approval    520.1367
                                            Pharmaceuticals     Suspension          as a generic copy
                                            Pvt. Ltd.           (meloxicam oral     of NADA 141-213.
                                            (086101).           suspension 1.5mg/
                                                                mL).
August 5, 2025.............       200-818  Bimeda Animal       MOXICLOPRID for     Original approval    524-1146
                                            Health Ltd.         dogs                as a generic copy
                                            (061133).           (imidacloprid and   of NADA (141-251).
                                                                moxidectin).
August 14, 2025............       200-794  Cronus Pharma       MELOXISOL           Original approval    520.1367
                                            Specialities        (meloxicam oral     as a generic copy
                                            India Private       suspension 0.5mg/   of NADA 141-213.
                                            Ltd. (069043).      mL).
August 28, 2025............       200-821  Parnell             Isoflurane          Original approval    529.1186
                                            Technologies Pty.   (isoflurane         as a generic copy
                                            Ltd. (068504).      liquid).            of NADA 135-773.
August 28, 2025............       200-819  Bimeda Animal       GAMROZYNE           Original approval    522.1014
                                            Health Ltd.         (gamithromycin).    as a generic copy
                                            (061133).                               of NADA 141-328.
September 19, 2025.........       200-824  Felix               Dexmedetomidine     Original approval     522.558
                                            Pharmaceuticals     (dexmedetomidine    as a generic copy
                                            Pvt. Ltd.           hydrochloride       of NADA 141-267.
                                            (086101).           sterile
                                                                injectable
                                                                solution).
September 30, 2025.........       141-616  Zoetis Inc.,        DECTOMAX-CA1        Conditional           516.570
                                            (054771).           (doramectin         approval.
                                                                injectable
                                                                solution).
----------------------------------------------------------------------------------------------------------------
\1\ See 21 CFR 510.600(c) for sponsor addresses.

II. Withdrawal of Approval of Applications

    Elanco US Inc., 450 Elanco Circle, Indianapolis, IN 46211 (drug 
labeler code 058198) requested that FDA withdraw approval of the NADA 
listed in table 2 because the product information has been combined 
with NADA 010-918. No change to the regulatory text is required.

[[Page 5300]]



   Table 2--Applications for Which Approval Was Voluntarily Withdrawn
                 During July, August, and September 2025
------------------------------------------------------------------------
   Date of withdrawal of      Application                        21 CFR
          approval                No.         Product name      section
------------------------------------------------------------------------
August 02, 2023\1\.........       011-948  HYGROMIX 2.5          558.274
                                            (hygromycin B
                                            Type A medicated
                                            article).
------------------------------------------------------------------------
\1\ This withdrawal was not previously published.

III. Changes of Sponsor

    The sponsor of the approved applications listed in table 3 has 
informed FDA that they have transferred ownership of, and all rights 
and interest in, these applications to another sponsor. The regulations 
cited in table 3 are amended to reflect these actions.

 Table 3--Applications for Which Ownership Was Transferred to Another Sponsor During July, August, and September
                                                      2025
----------------------------------------------------------------------------------------------------------------
                                                        Transferring sponsor      New sponsor (drug      21 CFR
     Application No.              Product name           (drug labeler code)        labeler code)       section
----------------------------------------------------------------------------------------------------------------
141-136.................  BIO-COX (salinomycin sodium  Zoetis Inc. (054771)..  Phibro Animal Health      558.550
                           Type A medicated article)                            Corp. (066104).
                           and BMD (bacitracin
                           methylenedisalicylate Type
                           A medicated article).
091-749.................  TYLAN 10 SULFA-G and TYLAN   Do....................  Do....................    558.630
                           40 SULFA-G (tylosin
                           phosphate Type A medicated
                           article and sulfamethazine
                           Type A medicated article).
----------------------------------------------------------------------------------------------------------------

IV. 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 516

    Administrative practice and procedure, Animal drugs, Confidential 
business information, Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, and 529

    Animal drugs.

21 CFR Part 556

    Animal drugs, Dairy products, Foods, Meat and meat products.

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 
516, 520, 522, 529, 556, and 558 are amended as follows:

PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

0
1. The authority citation for part 516 continues to read as follows:

    Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.


0
2. Add Sec.  516.570 to read as follows:


Sec.  516.570  Doramectin.

    (a) Specifications. Each milliliter of solution contains 10 
milligrams of doramectin.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in cattle--(1) Amount. 200 micrograms per 
kilogram (10 milligrams per 110 pounds).
    (2) Indications for use. For prevention and treatment of 
infestations caused by larvae of Cochliomyia hominivorax (myiasis), and 
prevention of reinfestation for 21 days in cattle.
    (3) Limitations. Consult your veterinarian for assistance in the 
diagnosis, treatment, and control of parasitism. Administer as a single 
subcutaneous or intramuscular injection. Do not slaughter cattle for 
human consumption within 35 days of treatment. Not for use in female 
dairy cattle 20 months of age or older. A withdrawal period has not 
been established for this product in preruminating calves. Do not use 
in calves to be processed for veal.

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.


Sec.  520.370  [Amended]

0
4. In Sec.  520.370, in paragraph (b)(1), remove the text ``No. 
017033'' and in its place add the text ``Nos. 017033 and 086101''.

0
5. Revise the heading of Sec.  520.998 to read as follows:


Sec.  520.998  Fluralaner chewable tablets.

* * * * *

0
6. Add Sec.  520.999 to read as follows:


Sec.  520.999  Fluralaner oral solution.

    (a) Specifications. Each milliliter (mL) of solution contains 10 
milligrams (mg) fluralaner.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in laying hens and replacement chickens--(1) 
Amount. Administer orally to chickens via the drinking water as 2 
single doses, spaced 7 days apart, with each dose consumed over a 
period of 6 to 24 hours. Each dose is 0.5 mg fluralaner/kilogram (kg) 
(0.227 mg/pound (mg/lb)) body weight, equivalent to 0.05 mL fluralaner 
oral solution/kg body weight (0.023 mL/lb).
    (2) Indications for use. For the treatment and control of northern 
fowl mites (Ornithonyssus sylviarum).
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian. Chickens must not be slaughtered 
for human consumption for 11 days after the last treatment. No egg 
discard is required when used according to the labeling.


Sec.  520.1010  [Amended]

0
7. In Sec.  520.1010, in paragraph (b)(1), remove the text ``No. 
000010'' and in its place add the text ``Nos. 000010 and 086117''.

[[Page 5301]]


0
8. In Sec.  520.1367, revise paragraphs (b)(1) and (2) and the last 
sentence in paragraph (c)(1) to read as follows:


Sec.  520.1367  Meloxicam.

* * * * *
    (b) * * *
    (1) Nos. 000010 and 069043 for use of the products described in 
paragraph (a) of this section; and
    (2) Nos. 013744, 055529, and 086101 for use of the product 
described in paragraph (a)(2) of this section.
    (c) * * *
    (1) * * * For all treatments after day 1, administer 0.045 mg/lb 
(0.1 mg/kg) body weight once daily.
* * * * *

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
9. The authority citation for part 522 continues to read as follows:

    Authority: 21 U.S.C. 360b.


Sec.  522.558  [Amended]

0
10. In Sec.  522.558, in paragraph (b)(1), remove the text ``and 
086117'' and in its place add the text ``086101, and 086117''.

0
11. Add Sec.  522.998 to read as follows:


Sec.  522.998  Fluralaner.

    (a) Specifications. The product is supplied in two vials, one vial 
containing 2.51 grams of sterile fluralaner and one vial containing the 
required 15 milliliters (mL) of sterile vehicle for constitution. Each 
mL of constituted suspension contains 150 milligrams (mg) fluralaner.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer as a single 
subcutaneous dose every 12 months or every 8 months in the case of 
potential exposure to Amblyomma americanum ticks. The subcutaneous dose 
volume is 0.1 mL of the constituted suspension/kilogram (kg) body 
weight (0.045 mL per pound (mL/lb)). This volume provides a dose of 15 
mg fluralaner per kilogram body weight (6.8 mg/lb).
    (2) Indications for use. Kills adult fleas and for the treatment 
and prevention of flea infestations (Ctenocephalides felis); for the 
treatment and control of tick infestations Ixodes scapularis (black-
legged tick), Dermacentor variabilis (American dog tick), and 
Rhipicephalus sanguineus (brown dog tick) for 12 months in dogs and 
puppies 6 months of age and older; and for the treatment and control of 
Amblyomma americanum (lone star tick) infestations for 8 months in dogs 
and puppies 6 months of age and older.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.


Sec.  522.1014  [Amended]

0
12. In Sec.  522.1014, in paragraph (b), remove the text ``No. 000010'' 
and in its place add the text ``Nos. 000010 and 061133''.

0
13. In Sec.  522.2680 revise paragraphs (d)(1)(ii)(A) and (B) as 
follows:


Sec.  522.2680  Zeranol.

* * * * *
    (d) * * *
    (1) * * *
    (ii) * * *
    (A) For increased rate of weight gain and improved feed efficiency 
in growing beef steers and heifers fed in confinement for slaughter.
    (B) For increased rate of weight gain in beef calves 2 months of 
age or older, in growing beef steers and heifers on pasture (stocker, 
feeder, and slaughter), and in growing beef steers and heifers in a dry 
lot.
* * * * *

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
14. The authority citation for part 529 continues to read as follows:

    Authority: 21 U.S.C. 360b.


Sec.  529.1186  [Amended]

0
15. In Sec.  529.1186, in paragraph (b), remove the text ``See Nos. 
017033, 054771, and 065085'' and in its place add the text ``See Nos. 
017033, 054771, 065085, and 068504''.

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
16. The authority citation for part 556 continues to read as follows:

    Authority: 21 U.S.C. 342, 360b, 371.


0
17. Add Sec.  556.290 to read as follows:


Sec.  556.290  Fluralaner.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
fluralaner is 10 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for parent fluralaner (marker 
residue) are:
    (1) Chickens. (i) Liver (target tissue): 320 ppb.
    (ii) Muscle: 110 ppb.
    (iii) Eggs: 2500 ppb.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  520.999 of this chapter.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
18. The authority citation for part 558 continues to read as follows:

    Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

0
19. In Sec.  558.330, revise paragraph (e)(1)(v) to read as follows:


Sec.  558.330  Lubabegron.

* * * * *
    (e) * * *
    (1) * * *

[[Page 5302]]



----------------------------------------------------------------------------------------------------------------
     Lubabegron (as lubabegron         Combination in
      fumarate) in grams/ton             grams/ton       Indications for use        Limitations         Sponsors
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(v) 1.25 to 4.54..................  Monensin, 10 to 40   Growing beef         Melengestrol acetate        058198
                                     and melengestrol     heifers fed in       Type C top-dress           016592
                                     acetate, 0.25 to 2.  confinement for      medicated feed (0.5 to
                                                          slaughter: For       2 lb(s) per head per
                                                          increased rate of    day) must be top
                                                          weight gain,         dressed onto or mixed
                                                          improved feed        at feeding with a Type
                                                          efficiency,          C medicated feed
                                                          suppression of       containing 1.25 to
                                                          estrus (heat), for   4.54 g/ton lubabegron
                                                          reduction of         and 10 to 40 g/ton
                                                          ammonia gas          monensin, to provide
                                                          emissions per        0.25 to 0.5 mg
                                                          pound of live        melengestrol acetate
                                                          weight and hot       and 13 to 90 mg
                                                          carcass weight,      lubabegron per head
                                                          and for the          per day, and 0.14 to
                                                          prevention and       0.42 mg monensin per
                                                          control of           pound of body weight
                                                          coccidiosis caused   per day, depending
                                                          by Eimeria bovis     upon severity of
                                                          and Eimeria          challenge, up to a
                                                          zuernii during the   maximum of 480 mg
                                                          last 14 to 91 days   monensin per head per
                                                          on feed.             day. Feed as the sole
                                                                               ration during the last
                                                                               14 to 91 days on feed.
                                                                               See special labeling
                                                                               considerations in
                                                                               paragraph (d) of this
                                                                               section, and in Sec.
                                                                               Sec.   558.342(d) and
                                                                               558.355(d). Lubabegron
                                                                               fumarate as provided
                                                                               by No. 058198;
                                                                               monensin as provided
                                                                               by No. 058198 or
                                                                               016592; melengestrol
                                                                               acetate as provided by
                                                                               No. 054771 in Sec.
                                                                               510.600(c) of this
                                                                               chapter.
----------------------------------------------------------------------------------------------------------------

* * * * *

0
20. In Sec.  558.550, revise paragraphs (e)(1)(ii) through (iv) to read 
as follows:


Sec.  558.550  Salinomycin.

* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
  Salinomycin sodium activity in       Combination in
             grams/ton                   grams/ton       Indications for use        Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(ii) 40 to 60.....................  Bacitracin (as feed  Broiler chickens     Feed continuously as        016592
                                     grade bacitracin     and replacement      sole ration.               066104
                                     methylenedisalicyl   chickens. Not for    Discontinue use prior
                                     ate) 4 to 50.        use in laying        to sexual maturity.
                                                          hens: For the        The dosage of
                                                          prevention of        salinomycin sodium
                                                          coccidiosis caused   should be adjusted to
                                                          by Eimeria           meet the severity of
                                                          tenella, E.          the coccidial
                                                          necatrix, E.         challenge, which
                                                          acervulina, E.       varies with
                                                          maxima, E.           environmental and
                                                          brunetti, and E.     management conditions.
                                                          mivati, and for      May be fatal if fed to
                                                          increased rate of    adult turkeys or
                                                          weight gain and      horses. Salinomycin as
                                                          improved feed        provided by No.
                                                          efficiency.          016592; bacitracin
                                                                               methylenedisalicylate
                                                                               as provided by No.
                                                                               066104 in Sec.
                                                                               510.600(c) of this
                                                                               chapter.
(iii) 40 to 60....................  Bacitracin (as feed  Broiler chickens     Feed continuously as        066104
                                     grade bacitracin     and replacement      sole ration.
                                     methylenedisalicyl   chickens. Not for    Discontinue use prior
                                     ate) 50.             use in laying        to sexual maturity.
                                                          hens: For the        The dosage of
                                                          prevention of        salinomycin sodium
                                                          coccidiosis caused   should be adjusted to
                                                          by Eimeria           meet the severity of
                                                          tenella, E.          the coccidial
                                                          necatrix, E.         challenge, which
                                                          acervulina, E.       varies with
                                                          maxima, E.           environmental and
                                                          brunetti, and E.     management conditions.
                                                          mivati, and as an    May be fatal if fed to
                                                          aid in the           adult turkeys or
                                                          prevention of        horses. Salinomycin as
                                                          necrotic enteritis   provided by No.
                                                          caused or            016592; bacitracin
                                                          complicated by       methylenedisalicylate
                                                          Clostridium spp.     as provided by No.
                                                          or other organisms   066104 in Sec.
                                                          susceptible to       510.600(c) of this
                                                          bacitracin           chapter.
                                                          methylenedisalicyl
                                                          ate.
(iv) 40 to 60.....................  Bacitracin (as feed  Broiler chickens     Feed continuously as        066104
                                     grade bacitracin     and replacement      the sole ration.
                                     methylenedisalicyl   chickens. Not for    Discontinue use prior
                                     ate) 100 to 200.     use in laying        to sexual maturity.
                                                          hens: For the        The dosage of
                                                          prevention of        salinomycin sodium
                                                          coccidiosis caused   should be adjusted to
                                                          by Eimeria           meet the severity of
                                                          tenella, E.          the coccidial
                                                          necatrix, E.         challenge, which
                                                          acervulina, E.       varies with
                                                          maxima, E.           environmental and
                                                          brunetti, and E.     management conditions.
                                                          mivati, and as an    To control a necrotic
                                                          aid in the control   enteritis outbreak,
                                                          of necrotic          start medication at
                                                          enteritis caused     the first clinical
                                                          or complicated by    signs of disease. The
                                                          Clostridium spp.     bacitracin
                                                          or other organisms   methylenedisalicylate
                                                          susceptible to       dosage range permitted
                                                          bacitracin           provides for different
                                                          methylenedisalicyl   levels based on
                                                          ate.                 severity of the
                                                                               infection. Consult a
                                                                               poultry diagnostic
                                                                               laboratory or
                                                                               pathologist to
                                                                               determine the
                                                                               diagnosis and advice
                                                                               regarding the optimal
                                                                               level of bacitracin
                                                                               methylenedisalicylate.
                                                                               Administer
                                                                               continuously for 5-7
                                                                               days or as long as
                                                                               clinical signs
                                                                               persist, and then
                                                                               reduce bacitracin
                                                                               methylenedisalicylate
                                                                               dosage to prevention
                                                                               level (50 g/ton). May
                                                                               be fatal if fed to
                                                                               adult turkeys or to
                                                                               horses. Salinomycin as
                                                                               provided by No.
                                                                               016592; bacitracin
                                                                               methylenedisalicylate
                                                                               as provided by No.
                                                                               066104 in Sec.
                                                                               510.600(c) in this
                                                                               chapter.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

[[Page 5303]]


0
21. In Sec.  558.625, revise paragraph (e)(2)(ix) to read as follows:


Sec.  558.625  Tylosin.

* * * * *
    (e) * * *
    (2) * * *

----------------------------------------------------------------------------------------------------------------
                                       Combination in
       Tylosin in grams/ton              grams/ton       Indications for use        Limitations         Sponsors
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(ix) 8 to 10......................  Monensin, 10 to 40   Growing beef         Feed as the sole ration     058198
                                     plus lubabegron      heifers fed in       during the last 14 to      016592
                                     (as lubabegron       confinement for      91 days on feed.
                                     fumarate), 1.25 to   slaughter: For       Melengestrol acetate
                                     4.54, plus           increased rate of    Type C top-dress
                                     melengestrol         weight gain,         medicated feed (0.5 to
                                     acetate, 0.25 to     improved feed        2.0 lb per head per
                                     2.0.                 efficiency,          day) must be top
                                                          suppression of       dressed onto or mixed
                                                          estrus (heat), for   at feeding with a Type
                                                          reduction of         C medicated feed
                                                          ammonia gas          containing 8 to 10 g/
                                                          emissions per        ton tylosin, 1.25 to
                                                          pound of live        4.54 g/ton lubabegron,
                                                          weight and hot       and 10 to 40 g/ton
                                                          carcass weight,      monensin, to provide
                                                          for the prevention   0.25 to 0.5 mg
                                                          and control of       melengestrol acetate,
                                                          coccidiosis caused   60 to 90 mg tylosin
                                                          by Eimeria bovis     per head per day, 13
                                                          and Eimeria          to 90 mg lubabegron
                                                          zuernii, and for     per head per day, and
                                                          reduction of         0.14 to 0.42 mg
                                                          incidence of liver   monensin per pound of
                                                          abscesses            body weight per day,
                                                          associated with      depending on severity
                                                          Fusobacterium        of challenge, up to
                                                          necrophorum and      480 mg monensin per
                                                          Arcanobacterium      head per day. See
                                                          pyogenes during      special labeling
                                                          the last 14 to 91    considerations in Sec.
                                                          days on feed.         Sec.   558.330(d),
                                                                               558.342(d), and
                                                                               558.355(d). Tylosin
                                                                               and monensin as
                                                                               provided by No. 058198
                                                                               or 016592; lubabegron
                                                                               fumarate as provided
                                                                               by No. 058198;
                                                                               melengestrol acetate
                                                                               as provided in No.
                                                                               054771 in Sec.
                                                                               510.600(c) of this
                                                                               chapter.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

Sec.  558.630  [Amended]

0
22. In Sec.  558.630:
0
a. In paragraph (b)(2), remove the text ``054771'' and in its place add 
the text ``066104''; and
0
b. In the table in paragraph (e)(2), in the ``Sponsor'' column, remove 
the text ``054771'' and in its place add the text ``066104''.

Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International 
Affairs.
[FR Doc. 2026-02331 Filed 2-5-26; 8:45 am]
BILLING CODE 4164-01-P


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