2026-02331: New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address
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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 July, August, and September 2025. 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
3,366 words as published, February 06, 2026. View the original →
Federal Register, Volume 91 Issue 25 (Friday, February 6, 2026) [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 [www.gpo.gov] [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, [email protected], 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: https://animaldrugsatfda.fda.gov/adafda/views/#/search. 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
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
What this changes
Amends 6 parts of the Code of Federal Regulations — the standing rules this notice rewrites.
- 21 CFR 516 New Animal Drugs for Minor Use and Minor Species
- 21 CFR 520 Oral Dosage Form New Animal Drugs
- 21 CFR 522 Implantation or Injectable Dosage Form New Animal Drugs
- 21 CFR 529 Certain Other Dosage Form New Animal Drugs
- 21 CFR 556 Tolerances for Residues of New Animal Drugs in Food
- 21 CFR 558 New Animal Drugs for Use in Animal Feeds
Documents
- Full text (Federal Register) · February 06, 2026
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