2026-13716: New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor
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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 January, February, and March 2026. The animal drug regulations are also being amended to improve their accuracy and readability.
The agency’s own summary, as published.
The rule, in full
5,310 words as published, July 07, 2026. View the original →
Federal Register, Volume 91 Issue 128 (Tuesday, July 7, 2026) [Federal Register Volume 91, Number 128 (Tuesday, July 7, 2026)] [Rules and Regulations] [Pages 41557-41564] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2026-13716] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts, 516, 520, 522, 524, 529, 556, and 558 [Docket No. FDA-2026-N-0002] New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor
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 January, February, and March 2026. The animal drug regulations are also being amended to improve their accuracy and readability.
Dates
This rule is effective July 7, 2026.
For Further Information Contact
James Delaney, Center for Veterinary Medicine, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, [email protected], 240-402-5677.
Supplementary Information
I. Approval of Applications
FDA is amending the animal drug regulations to reflect approval actions for NADAs, ANADAs, and CNADAs during January, February, and March 2026, 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, Conditional, and Supplemental Applications Approved During January, February, and March 2026 ---------------------------------------------------------------------------------------------------------------- Application Sponsor (drug Effect of the 21 CFR Date of approval No. labeler code \1\) Product name action sections ---------------------------------------------------------------------------------------------------------------- December 4, 2025............ 141-167 Intervet, Inc. EXZOLT CATTLE-CA Conditional 516.900 (000061). (fluralaner approval. 556.290(b)(2) topical solution). January 9, 2026............. 200-828 Parnell nixiFLOR Original 522.956 Technologies (florfenicol approval as a Pty. Ltd. and flunixin generic copy of (068504). meglumine) NADA 141-299. injectable solution. January 9, 2026............. 141-615 Pegasus KBROVET......... Original 516.1858 Laboratories, (potassium approval. 520.1858 Inc. (055246). bromide chewable tablets). January 12, 2026............ 200-833 Felix Maropitant Original 520.1315 Pharmaceuticals Citrate approval as a Pvt. Ltd. Chewable generic copy of (086101). Tablets. NADA 141-262. January 13, 2026............ 200-831 Norbrook Defendazole Original 520.905a Laboratories (fenbendazole). approval as a Ltd.. generic copy of RLNAD NADA 128- 620. January 13, 2026............ 141-518 Intervet, Inc. BRAVECTO PLUS Supplemental 524.1001 (000061). (fluralaner and approval. moxidectin topical solution). January 15, 2026............ 141-575 Boehringer VETMEDIN Supplemental 520.1782 Ingelheim Animal Solution approval. Health USA, Inc. (pimobendan (000010). oral solution). January 20, 2026............ 141-554 Boehringer NEXGARD PLUS Supplemental 520.35 Ingelheim Animal (afoxolaner, approval. Health USA, Inc. moxidectin, and (000010). pyrantel chewable tablets). January 29, 2026............ 200-761 Cronus Pharma Cronoquin Original 520.1310 Specialities Tablets approval as a India Private (marbofloxacin generic copy of Ltd. (069043). tablets). NADA 141-151. January 30, 2026............ 200-830 Parnell Sevoflurane Original 529.2110 Technologies (sevoflurane). approval as a Pty. Ltd. generic copy (068504). NADA 141-103. February 6, 2026............ 200-838 Felix Atipamezole Original 522.147 Pharmaceuticals Hydrochloride approval as a Pvt. Ltd. Injection generic copy of (086101). (atipamezole NADA 141-033. hydrochloride) sterile injectable solution. February 23, 2026........... 200-822 Baxter Healthcare ANIRANE Original 529.1186 Corporation (isoflurane). approval as a (010019). generic copy of NADA 135-773. February 23, 2026........... 200-841 Felix Firocoxib Original 520.928 Pharmaceuticals Tablets for approval as a Pvt. Ltd. Horses generic copy of (086101). (firocoxib). NADA 141-458. March 9, 2026............... 200-804 Cronus Pharma Robenacoxib Original 522.2075 Specialities Injection approval as a India Private (robenacoxib) generic copy of Ltd. (069043). Injectable NADA 141-443. Solution. March 10, 2026.............. 095-735 Elanco, US Inc, Rumensin 113 Supplemental 558.355 (058198). (monensin Type approval. A medicated article). March 16, 2026.............. 141-599 Intervet, Inc. BRAVECTO QUANTUM Supplemental 522.998 (000061). (fluralaner for approval. extended- release injectable suspension). March 23, 2026.............. 141-616 Zoetis (054771).. DECTOMAX -CA1 Supplemental 516.570 (doramectin approval. injection). ---------------------------------------------------------------------------------------------------------------- \1\ See 21 CFR 510.600(c) for sponsor addresses. [[Page 41558]]
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 two NADAs listed in table 2 because these products are no longer marketed. Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767-1861 (drug labeler code 054925), requested that FDA withdraw approval of four ANADAs listed in table 2 because these products are no longer 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 January, February, and March 2026 ---------------------------------------------------------------------------------------------------------------- Application 21 CFR Date of withdrawal of approval No. Product name section ---------------------------------------------------------------------------------------------------------------- February 27, 2026......................... 047-955 ROMPUN 20 mg/mL..................... 522.2662 February 27, 2026......................... 200-408 Butorphanol Tartrate Injection 2 mg/ 522.246 mL. February 27, 2026......................... 200-183 Vet Beta-Gen (gentamicin sulfate, 524.1044b betamethasone valerate). February 27, 2026......................... 200-188 Betagen Topical Spray (gentamicin 524.1044f sulfate, betamethasone valerate). February 27, 2026......................... 200-196 Miconosol (miconazole nitrate lotion/ 524.1443 spray 1%). February 27, 2026......................... 200-229 TRI-OCTIC Ointment (gentamicin 524.1044g sulfate, betamethasone valerate, clotrimazole). ----------------------------------------------------------------------------------------------------------------
III. Changes of Sponsor
The sponsors of the approved applications listed in table 3 have 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 January, February, and March 2026 ---------------------------------------------------------------------------------------------------------------- Transferring sponsor New sponsor (drug 21 CFR Application No. Product name (drug labeler code) labeler code) section ---------------------------------------------------------------------------------------------------------------- 200-771............. Methimazole solution.... Norbrook Laboratories Virbac AH, Inc. 520.1376 Ltd. (055529). (051311). 141-614............. LAVERDIA (verdinexor Anivive Lifesciences Dechra, Ltd. (043264).. 520.2700 tablets). Inc. (086121). 200-683............. CYCLEGUARD and MONOVET Zoetis (054771)........ Phibro (066104)........ 558.342 (melengestrol acetate Type A liquid medicated article and monensin Type A medicated article. 139-235............. BIO-COX and BACIFERM Do..................... Do..................... 558.550 (salinomycin sodium Type A medicated article and bacitracin zinc Type A medicated article to be used in the manufacture of Type C medicated feeds. 114-794............. AMPROL HI-E and BACIFERM Do..................... Do..................... 558.58 (amprolium with ethopabate Type A medicated article and bacitracin zinc Type A medicated article). 134-830............. Coban and Albac Do..................... Do..................... 558.355 (monensin Type A medicated article and bacitracin zinc Type A medicated article). ----------------------------------------------------------------------------------------------------------------
IV. Technical Amendments
FDA is making the following amendments to improve the accuracy and readability of the animal drug regulations. 21 CFR 520.522 is amended to revise language updated on the labeling for ``Conditions for Use.'' 21 CFR 558.625 is amended to revise language updated on the labeling for ``Indications for Use'' and ``Limitations'' with ractopamine hydrochloride.
V. 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, 524, 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, 524, 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. In Sec. 516.570, revise paragraph (c)(2) to read as follows:
Sec. 516.570 Doramectin. * * * * * (c) * * * (2) Indications for use. For prevention and treatment of infestations caused by New World screwworm (Cochliomyia [[Page 41559]] hominivorax) larvae (myiasis), and prevention of reinfestation for 21 days. * * * * * 0
3. Add Sec. 516.900 to subpart E to read as follows:
Sec. 516.900 Fluralaner. (a) Specifications. Each milliliter (mL) of solution contains 50 milligrams (mg) of fluralaner (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter. (c) Conditions of use--(1) Amount. 2.5 mg per kilogram (1.13 mg per one pound). (2) Indications for use. For the prevention and treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis) and treatment and control of cattle fever tick (Rhipicephalus microplus) in beef cattle 2 months of age and older and replacement dairy heifers less than 20 months of age. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Environmental temperature affects the withdrawal period. Cattle must not be slaughtered for human consumption within 98 days of treatment. If cattle are continuously exposed to temperatures at or above 60 [deg]F after product administration, then cattle may be slaughtered for human consumption 44 days after treatment. Violative residues may result if cattle are exposed to temperatures below 60 [deg]F after administration and are slaughtered at 44 days. Not for use in female dairy cattle 20 months of age or older, including dry dairy cows: use in these cattle may cause drug residues in milk and/or calves born to these cows or heifers. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. Sec. 516.1858 [Removed] 0
4. Remove Sec. 516.1858.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS 0
6. In Sec. 520.35, revise paragraph (c)(2) to read as follows:
Sec. 520.35 Afoxolaner, 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 adult hookworm (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala) and roundworm (Toxocara canis and Toxascaris leonina) infections. Kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), Dermacentor variabilis (American dog tick), Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), and Haemaphysalis longicornis (longhorned tick) infestations for 1 month in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater. For the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. * * * * * 0
7. In Sec. 520.43, revise paragraph (c)(2) to read as follows:
Sec. 520.43 Afoxolaner. * * * * * (c) * * * (2) Indications for use. Kills adult fleas and for the treatment and prevention of flea infestations (Ctenocephalides felis); and the treatment and control of Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (longhorned tick) infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for 1 month; and for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. * * * * * 0
8. Add Sec. 520.136 to read as follows:
Sec. 520.136 Atinvicitinib tablets. (a) Specifications. Each tablet contains 4.8, 7.2, 21.6, or 31.6 milligrams (mg) of atinvicitinib. (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter. (c) Conditions of use--(1) Amount. Administer 0.36 to 0.54 mg atinvicitinib per pound (0.8 to 1.2 mg atinvicitinib per kilogram) of body weight, once daily, with food. (2) Indications for use. For the control of pruritus associated with allergic dermatitis in dogs 6 months of age and older. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 0
9. In Sec. 520.522, revise paragraph (d)(1) introductory text to read
as follows: Sec. 520.522 Cyclosporine. * * * * * (d) * * * (1) Dogs. Use capsules described in paragraph (a)(1) of this section or solution as described in paragraph (a)(2) of this section as follows: * * * * * 0
10. In Sec. 520.905a, revise paragraph (b) to read as follows:
Sec. 520.905a Fenbendazole suspension. * * * * * (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as follows: (1) No. 000061 as in paragraph (e) of this section. (2) No. 055529 as in paragraphs (e)(2) and (4) of this section. * * * * * 0
11. In Sec. 520.928, revise paragraph (b)(2) to read as follows:
Sec. 520.928 Firocoxib tablets. * * * * * (b) * * * (2) Nos. 000010, 055246, and 086101 for use of the product described in paragraph (a)(2) of this section as in paragraph (c)(2) of this section. * * * * * Sec. 520.1310 [Amended] 0
12. In Sec. 520.1310, in paragraph (b)(1), remove ``Nos. 017033,
054771, and 086117'' and in its place add ``Nos. 017033, 054771, 069043, and 086117''. 0
13. In Sec. 520.1315, revise paragraphs (a) and (b) to read as
follows: Sec. 520.1315 Maropitant. (a) Specifications. (1) Each tablet contains 16, 24, 60, or 160 milligrams (mg) maropitant as maropitant citrate. (2) Each chewable tablet contains 16, 24, 60, or 160 mg maropitant as maropitant citrate. (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter: (1) Nos. 054771, 086101, and 086117 for use of the product described in paragraph (a)(1) of this section as in paragraph (c) of this section. (2) No. 086101 for use of the product described in paragraph (a)(2) of this section as in paragraph (c) of this section. * * * * * Sec. 520.1376 [Amended] 0
14. In Sec. 520.1376, in paragraph (b), remove ``055529'' and in its
place add ``051311''. [[Page 41560]] 0
15. In Sec. 520.1782, revise paragraph (c)(2) to read as follows:
Sec. 520.1782 Pimobendan solution. * * * * * (c) * * * (2) Indications for use. For the delay of onset of congestive heart failure (CHF) in dogs with Stage B2 preclinical myxomatous mitral valve disease (MMVD). Stage B2 preclinical MMVD refers to dogs with asymptomatic MMVD that have a moderate or loud mitral murmur due to mitral regurgitation and cardiomegaly. For the management of the signs of mild, moderate, or severe CHF in dogs due to clinical MMVD or dilated cardiomyopathy (DCM); for use with concurrent therapy for CHF (e.g., furosemide, etc.) as appropriate on a case-by-case basis. * * * * * 0
16. Add Sec. 520.1858 to read as follows:
Sec. 520.1858 Potassium bromide chewable tablets. (a) Specifications. Each chewable tablet contains 250 or 500 milligrams (mg) potassium bromide. (b) Sponsor. See No. 055246 in Sec. 510.600(c) of this chapter. (c) Conditions of use--(1) Amount. Administer 25 to 68 mg per kilogram (11 to 31 mg per pound) of body weight. The dosage should be adjusted based on monitoring of clinical response of the individual patient. (2) Indications for use. For the control of seizures associated with idiopathic epilepsy in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Sec. 520.2700 [Amended] 0
17. In Sec. 520.2700, in paragraph (b), remove ``086121'' and in its
place add ``043264''. PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0
18. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b. Sec. 522.147 [Amended] 0
19. In Sec. 522.147, in paragraph (b), remove ``Nos. 015914, 052483,
068504, and 069043'' and in its place add ``Nos. 015914, 052483, 068504, 069043, and 086101''. 0
20. In Sec. 522.246:
0 a. Remove paragraph (b)(2); 0 b. Redesignate paragraph (b)(3) as paragraph (b)(2); and 0 c. Revise newly redesignated paragraph (b)(2). The revision reads as follows: Sec. 522.246 Butorphanol. * * * * * (b) * * * (2) Nos. 000061, 017033, and 059399 for use of the product described in paragraph (a)(3) of this section as in paragraph (d)(3) of this section. * * * * * Sec. 522.533 [Amended] 0
23. In Sec. 522.956, in paragraph (b), remove ``No. 000061'' and in
its place add ``Nos. 000061 and 068504''. 0
24. In Sec. 522.998, revise paragraph (c)(2) to read as follows:
Sec. 522.998 Fluralaner. * * * * * (c) * * * (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), Rhipicephalus sanguineus (brown dog tick), and Amblyomma maculatum (Gulf Coast 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. * * * * * Sec. 522.2075 [Amended] 0
25. In Sec. 522.2075, in paragraph (b), remove ``No. 058198'' and in
its place add ``Nos. 058198 and 069043''. Sec. 522.2662 [Amended] 0
26. In Sec. 522.2662, in paragraph (b)(3), remove ``Nos. 043264 and
061651'' and in its place add ``No. 061651''. PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 0
28. In Sec. 524.1001, revise paragraph (c)(2) to read as follows:
Sec. 524.1001 Fluralaner and moxidectin. * * * * * (c) * * * (2) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm (Toxocara cati, fourth-stage larvae, immature adults, and adults) and hookworm (Ancylostoma tubaeforme, fourth-stage larvae, immature adults, and adults); kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations (Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), Haemaphysalis longicornis (Asian longhorned tick), and Amblyomma maculatum (Gulf Coast tick)) for 2 months in cats and kittens 6 months of age and older and weighing 2.6 lb or greater. * * * * * Sec. 524.1044b [Amended] 0
29. In Sec. 524.1044b, in paragraph (b), remove ``Nos. 000061 and
054925'' and in its place add ``No. 000061''. Sec. 524.1044f [Amended] 0
30. In Sec. 524.1044f, in paragraph (b), remove ``Nos. 000061, 017033,
054925, 058005, and 058829'' and in its place add ``Nos. 000061, 017033, 058005, and 058829''. 0
31. In Sec. 524.1044g:
0 a. Remove paragraph (b)(2); 0 b. Redesignate paragraphs (b)(3) and (4) as paragraphs (b)(2) and (3), respectively, and 0 c. Revise paragraph (c)(1)(i). The revision reads as follows: Sec. 524.1044g Gentamicin, betamethasone, and clotrimazole ointment. * * * * * (c) * * * (1) * * * (i) From 7.5- or 15-g tubes; 10-, 12.5-, or 30-g bottles: 4 drops for dogs weighing less than 30 pounds (lb) or 8 drops for dogs weighing 30 lb or more. * * * * * Sec. 524.1443 [Amended] 0
32. In Sec. 524.1443, in paragraph (b)(2), remove ``Nos. 054925 and
058829'' and in its place add ``No. 058829''. PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS 0
33. The authority citation for part 529 continues to read as follows:
Authority: 21 U.S.C. 360b. [[Page 41561]] Sec. 529.1186 [Amended] 0
34. In Sec. 529.1186, in paragraph (b), remove ``Nos. 017033, 054771,
and 065085'' and in its place add ``Nos. 010019, 017033, 054771, and 065085''. Sec. 529.2110 [Amended] 0
35. In Sec. 529.2110, in paragraph (b), remove ``Nos. 017033, 054771,
and 065085'' and in its place add ``Nos. 017033, 054771, 065085, and 068504''. PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD 0
37. In Sec. 556.290, add paragraph (b)(2) and revise paragraph (c) to
read as follows: Sec. 556.290 Fluralaner. * * * * * (b) * * * (2) Cattle. (i) Liver (target tissue): 500 ppb. (ii) Muscle: 350 ppb. (c) Related conditions of use. See Sec. Sec. 516.900 and 520.999 of this chapter. PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 0
38. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371. 0
39. In Sec. 558.58, revise paragraph (e)(4) to read as follows:
Sec. 558.58 Amprolium and ethopabate. * * * * * (e) * * * ---------------------------------------------------------------------------------------------------------------- Amprolium and ethopabate in Combination in Indications for grams per ton grams per ton use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (4) Amprolium 113.5 and Bacitracin (as 2. Broiler Feed as the sole ration 066104 ethopabate 36.3. feed grade chickens: As an from the time birds bacitracin zinc) aid in prevention are placed on litter 4 to 50. of coccidiosis until past the time where severe when coccidiosis is exposure to ordinarily a hazard, coccidiosis from up to 16 weeks of age. Eimeria If losses exceed 0.5% acervulina, E. in a 2-day period, maxima, and E. obtain an accurate brunetti is diagnosis and follow likely to occur; the instructions of for improved feed your veterinarian or efficiency. poultry pathologist. Do not feed to chickens producing eggs for human consumption. Not for chickens over 16 weeks of age. Do not feed as a treatment for outbreaks of coccidiosis. Do not change the litter while giving this feed unless absolutely necessary. Use as the sole source of amprolium. Do not use in feeds containing bentonite. Bacitracin zinc as provided by No. 054771 in Sec. 510.600(c) of this chapter.. * * * * * * * ---------------------------------------------------------------------------------------------------------------- * * * * * 0
40. In Sec. 558.342, revise paragraph (e)(1)(iv) to read as follows:
Sec. 558.342 Melengestrol. * * * * * (e) * * * (1) * * * ---------------------------------------------------------------------------------------------------------------- Melengestrol acetate in mg/head/ Combination in Indications for day grams/ton use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (iv) 0.25 to 0.5............... Monensin, 10 to 40 Growing beef At the rate of 0.5 to 016592 heifers fed in 2.0 lb/head/day, a 066104 confinement for Type C top-dress 058198 slaughter: For medicated feed increased rate of containing 0.25 to 2 g weight gain, melengestrol acetate improved feed per ton must be top efficiency, and dressed onto or mixed suppression of at feeding with a Type estrus (heat); C medicated feed and for the containing 10 to 40 g prevention and of monensin per ton to control of provide 0.25 to 0.5 mg coccidiosis due melengestrol acetate/ to Eimeria bovis head/day and 0.14 to and E. zuernii. 0.42 mg monensin/lb body weight, depending on severity of coccidiosis challenge, up to 480 mg monensin/ head/day. See Sec. 558.355(d) of this chapter. Monensin as provided by No. 016592 or 058198; melengestrol acetate as provided by No. 016952, 066104, or 058198 in Sec. 510.600(c) of this chapter. ---------------------------------------------------------------------------------------------------------------- * * * * * 0
41. In Sec. 558.355, revise paragraphs (a), (e)(1)(xi), (e)(4)(v)
introductory text, and (e)(4)(v)(A) to read as follows: Sec. 558.355 Monensin. (a) Specifications. Type A medicated articles containing 45, 60, 90.7, 110, or 113.4 grams monensin, USP, per pound. * * * * * (e) * * * (1) * * * [[Page 41562]] ---------------------------------------------------------------------------------------------------------------- Combination in Indications for Monensin in grams/ton grams/ton use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (xi) 90 to 110................. Bacitracin (as Broiler chickens: Feed as the sole 066104 feed grade As an aid in the ration. Do not allow bacitracin zinc), prevention of horses, other equines, 4 to 50. coccidiosis mature turkeys, or caused by Eimeria guinea fowl access to necatrix, E. feed containing tenella, E. monensin. Ingestion of acervulina, E. monensin by horses and brunetti, E. guinea fowl has been mivati, and E. fatal. In the absence maxima, and for of coccidiosis in increased rate of broiler chickens, the weight gain and use of monensin with improved feed no withdrawal period efficiency. may limit feed intake resulting in reduced weight gain. Not for broiler breeder replacement chickens. Bacitracin zinc as provided by No. 054771 in 510.600(c) of this chapter. * * * * * * * ---------------------------------------------------------------------------------------------------------------- * * * * * (4) * * * ---------------------------------------------------------------------------------------------------------------- Monensin amount Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (v) 1,620 grams per ton of mineral Growing beef steers and Feed at a rate of 50 to 200 016592 granules as specified in paragraph heifers on pasture milligrams per head per day. 058198 (e)(4)(v)(A) of this section. (stocker, feeder, and During the first 5 days of slaughter) or in a dry feeding, cattle should lot and replacement beef receive no more than 100 and dairy heifers: For milligrams per day. Do not increased rate of weight feed additional salt or gain, and for prevention minerals. Do not mix with and control of grain or other feeds. coccidiosis due to Monensin is toxic to cattle Eimeria bovis and E. when consumed at higher than zuernii. approved levels. Stressed and/or feed- and/or water- deprived cattle should be adapted to the pasture and to unmedicated mineral supplement before using the monensin mineral supplement. ---------------------------------------------------------------------------------------------------------------- (A) Specifications. Use as free-choice Type C medicated feed formulated as mineral granules as follows: ------------------------------------------------------------------------ International Ingredient Percent feed No. ------------------------------------------------------------------------ Monocalcium phosphate (21% phosphorus, 29.49 6-01-082 15% calcium)........................... Sodium chloride (salt).................. 24.37 6-04-152 Dried cane molasses..................... 20.0 4-04-695 Ground limestone (33% calcium) or 13.75 6-02-632 calcium carbonate (38% calcium)........ Cane molasses........................... 3.0 4-04-696 Processed grain by-products (as approved 5.0 .............. by AAFCO).............................. Vitamin/trace mineral premix \1\........ 2.5 .............. Monensin Type A article, 90.7 grams per 0.89 .............. pound \2\.............................. Antidusting oil......................... 1.0 .............. ------------------------------------------------------------------------ \1\ Content of vitamin and trace mineral premixes may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide should comply with FDA Compliance Policy Guide Sec. 651.100 (CPG 7125.18). \2\ To provide 1,620 g monensin per ton, use 17.8 lb (0.89%) of a monensin Type A medicated article containing 90.7 g monensin per pound. If using a monensin Type A medicated article containing 113.4 grams monensin per pound, use 14.2 lb (0.71%), subtracting ground limestone. * * * * * 0
42. In Sec. 558.550, revise paragraph (e)(1)(v) to read as follows:
Sec. 558.550 Salinomycin. * * * * * (e) * * * (1) * * * [[Page 41563]] ---------------------------------------------------------------------------------------------------------------- Combination in Indications for Salinomycin in grams/ton grams/ton use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (v) 40 to 60................... Bacitracin (as Broiler chickens: Feed as the sole 016592 feed grade For the ration. The dosage of 066104 bacitracin zinc), prevention of salinomycin sodium 10 to 50. coccidiosis should be adjusted to caused by Eimeria meet the severity of tenella, E. coccidial challenge, necatrix, E. which varies with acervulina, E. environmental and maxima, E. management conditions. brunetti, and E. Do not feed to mivati, and for chickens producing increased rate of eggs for human weight gain. consumption. May be fatal if accidently fed to adult turkeys or horses. Do not use in Type C medicated feeds containing pellet binders. Bacitracin zinc as provided by No. 054771 in Sec. 510.600(c) of this chapter. * * * * * * * ---------------------------------------------------------------------------------------------------------------- * * * * * 0
43. In Sec. 558.625, revise paragraphs (e)(1)(v), (x), and (xiii) to
read as follows: Sec. 558.625 Tylosin. * * * * * (e) * * * (1) * * * ---------------------------------------------------------------------------------------------------------------- Combination in Indications for Tylosin in grams/ton grams/ton use Limitations Sponsors ---------------------------------------------------------------------------------------------------------------- * * * * * * * (v) 40 or 100.................. Ractopamine For increased rate Feed as the sole ration 016592 hydrochloride,. of weight gain, to finishing swine 054771 4.5 to 9.......... improved feed weighing at least 150 058198 efficiency, lb for the last 45 to increased carcass 90 lb (group average) leanness, control of weight gain prior of swine to slaughter. Feed 100 dysentery g of tylosin per ton associated with of complete feed for Brachyspira at least three weeks, hyodysenteriae, followed by 40 g and control of tylosin per ton of porcine complete feed until proliferative pigs reach market enteropathies weight. Ractopamine (PPE, ileitis) hydrochloride use may associated with increase the number of Lawsonia injured, lame, and/or intracellularis fatigued pigs during in finishing marketing. Behavioral swine weighing at signs such as least 150 lb and hyperactivity, fed a complete anxiety, and ration containing aggression have been at least 16% reported in pigs fed crude protein for ractopamine the last 45 to 90 hydrochloride. Tylosin lb of gain prior phosphate as provided to slaughter. Not by Nos. 058198 and for use in swine 016592; ractopamine intended for hydrochloride as breeding. provided by Nos. 058198 and 054771 in Sec. 510.600(c) of this chapter. [[Page 41564]] * * * * * * * (x) 40 to 100.................. Ractopamine For increased rate Feed as the sole ration .............. hydrochloride,. of weight gain, to finishing swine 4.5 to 9.......... improved feed weighing at least 150 efficiency, lb for the last 45 to increased carcass 90 lb (group average) leanness, the of weight gain prior treatment and to slaughter. Feed 40 control of swine to 100 grams of dysentery tylosin per ton of associated with complete feed for 2 to Brachyspira 6 weeks immediately hyodysenteriae, after medicating with and control of tylosin in drinking porcine water (250 mg tylosin proliferative per gallon) for 3 to enteropathies 10 days as in Sec. (PPE, ileitis) 520.2640(e)(3) of this associated with chapter. Ractopamine Lawsonia hydrochloride use may intracellularis increase the number of immediately after injured, lame, and/or medicating with fatigued pigs during tylosin in marketing. Behavioral drinking water in signs such as finishing swine hyperactivity, weighing at least anxiety, and 150 lb and fed a aggression have been complete ration reported in pigs fed containing at ractopamine least 16% crude hydrochloride. Tylosin protein for the phosphate as provided last 45 to 90 lb by Nos. 058198 and of gain prior to 016592; ractopamine slaughter. Not hydrochloride as for use in swine provided by Nos. intended for 058198 and 054771 in breeding. Sec. 510.600(c) of this chapter. * * * * * * * (xiii) 100..................... Ractopamine For increased rate Feed as the sole ration 016592 hydrochloride,. of weight gain, to finishing swine 054771 4.5 to 9.......... improved feed weighing at least 150 058198 efficiency, lb for the last 45 to increased carcass 90 lb (group average) leanness, and of weight gain prior control of to slaughter. Feed 100 porcine g of tylosin per ton proliferative of complete feed for enteropathies 21 days. Ractopamine (PPE, ileitis) hydrochloride use may associated with increase the number of Lawsonia injured, lame, and/or intracellularis fatigued pigs during in finishing marketing. Behavioral swine weighing at signs such as least 150 lb and hyperactivity, fed a complete anxiety, and ration containing aggression have been at least 16% reported in pigs fed crude protein for ractopamine the last 45 to 90 hydrochloride. Tylosin lb of gain prior phosphate as provided to slaughter. Not by Nos. 058198 and for use in swine 016592; ractopamine intended for hydrochloride as breeding. provided by Nos. 058198 and 054771 in Sec. 510.600(c) of this chapter. ---------------------------------------------------------------------------------------------------------------- * * * * * Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2026-13716 Filed 7-6-26; 8:45 am] BILLING CODE 4164-01-P
Rulemaking docket
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Rule July 07, 2026New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor
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Rule July 07, 2026New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor
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- Full text (Federal Register) · July 07, 2026
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