2025-16079: New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address

1. The authority citation for part 510 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. 0

2. In Sec. 510.600:

0 a. In the table in paragraph (c)(1): 0 i. Revise the entries for ``ECO LLC'', ``Elanco US Inc.''; [[Page 40969]] 0 ii. Add in alphabetical order entries for ``Genus plc'' and ``Qilu Animal Health Products Co., Ltd.''; and 0 iii. Revise the entry for ``Sergeant's Pet Care Products, Inc''; 0 b. In the table in paragraph (c)(2), add entries in numerical order for ``086163'' and ``086205''; and revise the entries for ``021091''; ``058198'', and ``066916''. The revisions and additions read as follows: Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. * * * * * (c) * * * (1) * * * ------------------------------------------------------------------------ Firm name and address Drug labeler code ------------------------------------------------------------------------ * * * * * * * ECO LLC, 506 Carnegie Centre, Suite 400, 066916 Princeton, NJ 08540.............................. Elanco US Inc., 450 Elanco Circle, Indianapolis, 058198 IN 46221......................................... * * * * * * * Genus plc, 1525 River Road, Deforest, WI 53532.... 086205 * * * * * * * Qilu Animal Health Products Co., Ltd., No. 10688, 086163 Wenliang Road, Dongjia Town,..................... Licheng District Jinan, Shandong, 250100, China... * * * * * * * Sergeant's Pet Care Products LLC, 10077 S. 134th 021091 St., Omaha, NE 68138............................. * * * * * * * ------------------------------------------------------------------------ (2) * * * ------------------------------------------------------------------------ Drug labeler code Firm name and address ------------------------------------------------------------------------ * * * * * * * 021091...................... Sergeant's Pet Care Products LLC, 10077 S. 134th St., Omaha, NE 68138 * * * * * * * 058198...................... Elanco US Inc., 450 Elanco Circle, Indianapolis, IN 46221 * * * * * * * 066916...................... ECO LLC, 506 Carnegie Centre, Suite 400, Princeton, NJ 08540 * * * * * * * 086163...................... Qilu Animal Health Products Co., Ltd., No. 10688, Wenliang Road, Dongjia Town, Licheng District Jinan, Shandong, 250100, China * * * * * * * 086205...................... Genus plc, 1525 River Road, Deforest, WI 53532 * * * * * * * ------------------------------------------------------------------------ PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS 0

4. In Sec. 520.35, revise paragraph (c)(2) by adding a sentence at the

end of the paragraph to read as follows: Sec. 520.35 Afoxolaner, moxidectin, and pyrantel. * * * * * (c) * * * (2) * * * For the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. * * * * * Sec. 520.304 [Amended] 0

5. In Sec. 520.304, in paragraph (b)(1), remove the text ``Nos.

017033, 054771, 055529, and 082983'' and in its place add the text ``Nos. 054771, 055529, and 082983''. Sec. 520.446 [Amended] 0

6. In Sec. 520.446, in paragraph (b)(2), remove the text ``No.

051311'' and in its place add the text ``Nos. 051311 and 086101''. Sec. 520.812 [Amended] 0

7. In Sec. 520.812, in paragraph (b)(2), remove the text ``Nos. 017033

and 086117'' and in its place add the text ``Nos. 017033, 086117, and 086194''. 0

8. In Sec. 520.1287, revise the first sentence in paragraph (c)(2) to

read as follows: Sec. 520.1287 Lotilaner, moxidectin, praziquantel, and pyrantel. * * * * * (c) * * * (2) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina), hookworm (fourth stage larvae, immature adult, and adult Ancylostoma caninum and adult Uncinaria stenocephala), and tapeworm (Dipylidium caninum, Taenia [[Page 40970]] pisiformis, and Echinococcus granulosus) infections. * * * * * * * * 0

9. In Sec. 520.1375, revise paragraph (b) and (c)(1) to read as

follows: Sec. 520.1375 Methimazole tablets. * * * * * (b) Sponsors, See Nos. 043264 and 086101in Sec. 510.600 of this chapter. (c) * * * (1) Amount. The starting dose is 2.5 mg every 12 hours. Following 3 weeks of treatment, the dose should be titrated to effect based on individual serum total T4 (TT4) levels and clinical response. Dose adjustments should be made in 2.5 mg increments. The maximum total dosage is 20 mg per day divided, not to exceed 10 mg as a single administration. * * * * * 0

10. In Sec. 520.2090, revise paragraph (c)(2) to read as follows:

Sec. 520.2090 Sarolaner, moxidectin, and pyrantel. * * * * * (c) * * * (2) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina) and hookworm (L4, immature adult, and adult Ancylostoma caninum and adult Uncinaria stenocephala) infections. Kills adult fleas (Ctenocephalides felis) and is indicated for the treatment and prevention of flea infestations, the prevention of Dipylidium caninum (tapeworm) infections as a direct result of killing Ctenocephalides felis vector fleas on the treated dog, and the treatment and control of tick infestations with Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (Asian longhorned tick) for one month in dogs and puppies 8 weeks of age and older, and weighing 2.8 pounds or greater. For the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. * * * * * 0

11. In Sec. 520.2455:

0 a. Revise paragraph (b)(2); and 0 b. Remove paragraph (b)(4). The revision reads as follows: Sec. 520.2455 Tiamulin. * * * * * (b) * * * (2) No. 066104 for products described in paragraphs (a)(1) and (3) of this section. (3) * * * (c) * * * * * * * * PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0

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

Authority: 21 U.S.C. 360b. Sec. 522.311 [Amended] 0

13. In Sec. 522.311, in paragraph (b), remove the text ``Sponsor. See

No. 054771 in Sec. 510.600(c) of this chapter'' and in its place add the text ``Sponsors. See Nos. 054771 and 086163 in Sec. 510.600(c) of this chapter''. 0

14. In Sec. 522.480:

0 a. Revise paragraph (b); and 0 b. Remove paragraph (c)(3). The revision reads as follows: Sec. 522.480 Corticotropin. * * * * * (b) Sponsor. See No. 061133 in Sec. 510.600(c) of this chapter. (c) Conditions of use-- (1) * * * (2) * * * Sec. 522.970 [Amended] 0

15. In Sec. 522.970, in paragraph (b)(1), remove the text ``Nos.

000061, 055529, and 061133'' and in its place add the text ``Nos. 000061, 055529, 061133, and 069043''; and in paragraph (b)(3), remove the text ``Nos. 016592, 058198, and 069043'' and in its place add the text ``Nos. 016592 and 058198''. 0

16. In Sec. 522.1260, revise paragraph (e)(2)(iii) to read as follows:

Sec. 522.1260 Lincomycin. * * * * * (e) * * * (2) * * * (iii) Limitations. Do not treat within 48 hours of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 0

18. In Part 524, add Sec. 524.1144j to read as follows:

Sec. 524.1144j Gentamicin, posaconazole, and mometasone furoate otic suspension. (a) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter (b) Specifications. A 0.8 milliliters (mL) dose delivers 6.88 milligrams (mg) gentamicin, 2.08 mg posaconazole, and 1.68 mg mometasone furoate. (c) Conditions of use--This product should be administered by a veterinary professional. (1) Amount. The dose volume is 0.8 mL per affected ear. Verify the tympanic membrane is intact prior to administration. (2) Indications for use. For the treatment of otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius and Pseudomonas aeruginosa)) in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Sec. 524.1146 [Amended] 0

19. In Sec. 524.1146, in paragraph (b)(2), remove the text ``and

058198'' and in its place add the text ``058198, and 061133''; and in paragraph (b)(3), remove the text ``058198, and'' and in its place add the text ``058198, 061133, and''. 0

20. Add Sec. 524.1312 to read as follows:

Sec. 524.1312 Marbofloxacin, terbinafine, and dexamethasone otic suspension. (a) Specifications. Each single-use tube contains 15.1 milligrams (mg) marbofloxacin, 22.7 mg terbinafine, and 2.01 mg dexamethasone. (b) Sponsor. See No. 043264 in Sec. 510.600(c) of this chapter. (c) Conditions of use--(1) Amount. Administer one dose (1 tube) per affected ear once. Do not clean the ear canal for 30 days after administration. (2) Indications for use. For the treatment of otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius) in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. PART 528--INTENTIONAL GENOMIC ALTERATIONS IN ANIMALS 0

22. Add Sec. 528.2000 to read as follows:

Sec. 528.2000 Deletion of exon 7 of CD163 gene in domestic pigs. (a) Specifications. Deletion of one (heterozygous) or two (homozygous) copies of exon 7 of CD163 gene1(abbreviated CD163[Delta]E7) in domestic pigs (Sus scrofa domesticus). [[Page 40971]] (b) Sponsor. See No. 086205 in Sec. 510.600(c) of this chapter. (c) Conditions of use--(1) Intended use. Deletion of exon 7 of the CD163 gene in domestic pigs (Sus scrofa domesticus) is intended to confer resistance to porcine reproductive and respiratory syndrome virus (PRRSV) in homozygous pigs. Pigs carrying one or two copies of CD163DE7, and their offspring, are intended for breeding or to be used as sources of food. PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 0

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

Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371. 0

24. In Sec. 558.68, revise paragraphs (e)(1)(ii) and (vii) to read as

follows: Sec. 558.68 Avilamycin. * * * * * (e) * * * (1) * * * ---------------------------------------------------------------------------------------------------------------- Combination in Avilamycin in grams/ton grams/ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (ii) 13.6 to 40.9.............. Monensin, 90 to Broiler chickens: For Feed as the sole ration 016592 110. the prevention of for 21 consecutive 058198 mortality caused by days. Feed to chickens necrotic enteritis that are at risk of associated with developing, but not Clostridium yet showing clinical perfringens, and as an signs of, necrotic aid in the prevention enteritis associated of coccidiosis caused with Clostridium by Eimeria necatrix, perfringens. To assure

E. tenella, E. responsible

acervulina, E. antimicrobial drug use brunetti, E. mivati, in broiler chickens, and E. maxima. treatment administration must begin on or before 18 days of age. Monensin as provided by Nos. 016592 or 058198 in Sec. 510.600(c) of this chapter. See Sec. 558.355(d). * * * * * * * * * * * * * * (vii) 100...................... .................. For the treatment of Feed as a sole ration 066104 swine dysentery and for 3 weeks or until the control of porcine signs of disease proliferative (watery, mucoid, or enteropathies bloody stools) (ileitis) caused by disappear. Lawsonia intracellularis. * * * * * * * ---------------------------------------------------------------------------------------------------------------- 0 25. In Sec. 558.355, revise paragraphs (b)(2), (e)(1)(vii) and (xiv), and (e)(2)(ii) through (v) to read as follows: Sec. 558.355 Monensin. * * * * * (b) * * * (2) No. 016592 for use of a Type A medicated article containing 90.7 grams monensin, USP, per pound as in paragraphs (e)(1)(i), (e)(1)(ii), (e)(1)(vii), (e)(1)(xiv), (e)(2), (e)(3), (e)(4)(v), and (e)(5) of this section. * * * * * (e) * * * (1) * * * ---------------------------------------------------------------------------------------------------------------- Combination in Monensin in grams/ton grams/ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (vii) 90 to 110................ Bacitracin Broiler chickens: As an Feed as the sole 016592 methylenedisalicy aid in the prevention ration. Monensin as 058198 late, 5 to 25. of coccidiosis caused provided by Nos. by Eimeria necatrix, 016592 or 058198;

E. tenella, E. bacitracin

acervulina, E. methylenedisalicylate brunetti, E. mivati, as provided by No. and E. maxima, and for 066104 in Sec. increase in rate of 510.600(c) of this weight gain and chapter. See special improved feed labeling efficiency. considerations in paragraph (d) of this section.. * * * * * * * (xiv) 90 to 110................ Bambermycins, 1 to Broiler chickens: As an Feed as the sole 016592 2. aid in the prevention ration. Monensin as 058198 of coccidiosis caused provided by Nos. by Eimeria necatrix, 016592 or 058198;

E. tenella, E. bambermycins as

acervulina, E. provided by No. 016592 brunetti, E. mivati, in Sec. 510.600(c) and E. maxima, and for of this chapter. See increase in rate of special labeling weight gain and considerations in improved feed paragraph (d) of this efficiency. section.. * * * * * * * ---------------------------------------------------------------------------------------------------------------- (2) * * * [[Page 40972]] ---------------------------------------------------------------------------------------------------------------- Combination in Monensin in grams/ton grams/ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (ii) 54 to 90.................. Bacitracin Growing turkeys: For Feed continuously as 016592 methylenedisalicy the prevention of the sole ration. The 058198 late, 4 to 50. coccidiosis caused by optimum level depends 069254 Eimeria adenoeides, E. upon the severity of meleagrimitis, and E. coccidiosis exposure. gallopavonis, and for Monensin as provided increased rate of by Nos. 016592 or weight gain and 058198; bacitracin improved feed methylenedisalicylate efficiency. as provided by Nos. 066104 or 069254 in Sec. 510.600(c) of this chapter. See special labeling considerations in paragraph (d) of this section. (iii) 54 to 90................. Bacitracin Growing turkeys: For Feed continuously as 016592 methylenedisalicy the prevention of the sole ration. 058198 cate, 200. coccidiosis caused by Monensin as provided Eimeria adenoeides, E. by Nos. 016592 or meleagrimitis, and E. 058198; bacitracin gallopavonis, and as methylenedisalicylate an aid in the control as provided by No. of transmissible 066104 in Sec. enteritis complicated 510.600(c) of this by organisms chapter. See special susceptible to labeling bacitracin considerations in methylenedisalicylate. paragraph (d) of this section. (iv) 54 to 90.................. Bambermycins, 1 to Growing turkeys: For Feed continuously as 016592 2. the prevention of the sole ration. 058198 coccidiosis caused by Monensin as provided Eimeria adenoeides, E. by Nos. 016592 or meleagrimitis, and E. 058198; bambermycins gallopavonis, and for as provided by No. improved feed 016592 in Sec. efficiency. 510.600(c) of this chapter. See special labeling considerations in paragraph (d) of this section. (v) 54 to 90................... Bambermycins, 2... Growing turkeys: For Feed continuously as 016592 the prevention of sole ration. Monensin 058198 coccidiosis caused by as provided by Nos. Eimeria adenoeides, E. 016592 or 058198; meleagrimitis, and E. bambermycins as gallopavonis, and for provided by No. 016592 increased rate of in Sec. 510.600(c) weight gain and of this chapter. See improved feed special labeling efficiency. considerations in paragraph (d) of this section. ---------------------------------------------------------------------------------------------------------------- * * * * * 0 26. In Sec. 558.635, add paragraphs (e)(3)(ii) through (viii) to read as follows: Sec. 558.635 Virginiamycin. * * * * * (e) * * * (3) * * * ---------------------------------------------------------------------------------------------------------------- Combination in Virginiamycin grams/ton grams/ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (ii) 13.5 to 16.0.............. Monensin, 5 to 40. Growing beef steers and Feed at every feeding 066104 heifers fed in to provide 50 to 480 confinement for mg monensin/head/day slaughter: For and 85 to 240 mg improved feed virginiamycin/head/ efficiency and day. No additional reduction of incidence improvement in feed of liver abscesses. efficiency has been shown from feeding monensin at levels greater than 30 g/ton (360 mg monensin/head/ day). A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. See Sec. 558.355(d). (iii) 13.5 to 16.0............. Monensin, 10 to 40 Growing beef steers and Feed at every feeding 066104 heifers fed in to provide 0.14 to confinement for 0.42 mg monensin/lb slaughter: For the body weight per day, prevention and control depending on the of coccidiosis caused severity of by Eimeria bovis and coccidiosis challenge, Eimeria zuernii, and up to a maximum of 480 reduction of incidence mg monensin/head/day of liver abscesses. and 85 to 240 mg virginiamycin/head/ day. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. See Sec. 558.355(d). (iv) 13.5 to 16.0.............. Monensin, 5 to 40; Growing beef steers and Feed at every feeding 066104 and lubabegron, heifers fed in as sole ration to 1.25 to 4.54. confinement for provide 13 to 90 mg slaughter during the lubabegron/head/day, last 14 to 91 days on 50 to 480 mg monensin/ feed: For reduction of head/day and 85 to 240 ammonia gas emissions mg virginiamycin/head/ per pound of live day during the last 14 weight and hot carcass to 91 days on feed. No weight, improved feed additional improvement efficiency, and in feed efficiency has reduction of incidence been shown from of liver abscesses. feeding monensin at levels greater than 30 g/ton (360 mg monensin/ head/day). A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. See Sec. 558.355(d). [[Page 40973]] (v) 13.5 to 16.0............... Monensin, 10 to Growing beef steers and Feed at every feeding 066104 40; and heifers fed in as sole ration to lubabegron, 1.25 confinement for provide 13 to 90 mg to 4.54. slaughter during the lubabegron/head/day, last 14 to 91 days on 0.14 to 0.42 mg feed: For reduction of monensin/lb body ammonia gas emissions weight per day, per pound of live depending on the weight and hot carcass severity of weight, the prevention coccidiosis challenge, and control of up to a maximum of 480 coccidiosis caused by mg monensin/head/day Eimeria bovis and and 85 to 240 mg Eimeria zuernii, and virginiamycin/head/day reduction of incidence during the last 14 to of liver abscesses. 91 days on feed. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. See Sec. 558.355(d). (vi) 13.5 to 16.0.............. Monensin, 10 to Growing beef steers and Feed at every feeding 066104 40; and heifers fed in as a sole ration to ractopamine confinement for provide 70 to 430 mg hydrochloride, slaughter during the ractopamine 8.2 to 24.6. last 28 to 42 days on hydrochloride/head/ feed: For increased day, 0.14 to 0.42 mg rate of weight gain, monensin/lb of body improved feed weight per day, efficiency, the depending upon prevention and control severity of of coccidiosis caused coccidiosis challenge, by Eimeria bovis and up to a maximum of 480 Eimeria zuernii, and mg monensin/head/day reduction of incidence and 85 to 240 mg of liver abscesses. virginiamycin/head/day during the last 28 to 42 days on feed. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. See Sec. 558.355(d). (vii) 13.5 to 6.0.............. Monensin, 10 to Growing beef steers and Feed at every feeding 066104 40; and heifers fed in as a sole ration to ractopamine confinement for provide 90 to 430 mg hydrochloride, slaughter during the ractopamine 9.8 to 24.6. last 28 to 42 days on hydrochloride/head/ feed: For increased day, 0.14 to 0.42 mg rate of weight gain, monensin/lb of body improved feed weight per day, efficiency, increased depending upon carcass leanness, the severity of prevention and control coccidiosis challenge, of coccidiosis caused up to a maximum of 480 by Eimeria bovis and mg monensin/head/day Eimeria zuernii, and and 85 to 240 mg reduction of incidence virginiamycin/head/day of liver abscesses. during the last 28 to 42 days on feed. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. See Sec. 558.355(d). (viii) 13.5 to 16.0............ Monensin, 10 to Growing beef steers and Feed a minimum of 1.0 066104 40; and heifers fed in lb per head per day of ractopamine confinement for this Type C top-dress hydrochloride, slaughter during the medicated feed to not to exceed 800. last 28 to 42 days on provide 70 to 400 mg/ feed: For increased head/day ractopamine rate of weight gain hydrochloride during and improved feed the last 28 to 42 days efficiency, the on feed. Must be top prevention and control dressed onto or mixed of coccidiosis caused at feeding with a Type by Eimeria bovis and C medicated feed Eimeria zuernii, and containing 10 to 40 g/ reduction of incidence ton monensin and 13.5 of liver abscesses to 16 g/ton when ractopamine virginiamycin (90% dry hydrochloride is used matter basis), to as a top dress with provide 0.14 to 0.42 rations containing mg monensin/lb of body monensin and weight per day, virginiamycin. depending upon severity of coccidiosis challenge, up to a maximum of 480 mg monensin/head/day and 85 to 240 mg virginiamycin/head/ day. See Sec. 558.355(d). ---------------------------------------------------------------------------------------------------------------- Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2025-16079 Filed 8-21-25; 8:45 am] BILLING CODE 4164-01-P