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

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Parts 510, 520, 522, 524, 528, and 558</CFR> <DEPDOC>[Docket No. FDA-2025-N-0002]</DEPDOC> <SUBJECT>New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Final rule; technical amendments. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April, May, and June 2025. The animal drug regulations are also being amended to improve their accuracy and readability. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This rule is effective August 22, 2025. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Cathie Marshall, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-5693, <E T="03">cathie.marshall@fda.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Approval of Applications</HD> FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during April, May, and June 2025, as listed in table 1. Documentation of environmental review required under the National Environmental Policy Act, summaries of the basis of approval under the Freedom of Information Act (FOIA summaries), and marketing exclusivity and patent information are available at Animal Drugs @FDA: <E T="03">https://animaldrugsatfda.fda.gov/adafda/views/#/search.</E> <GPOTABLE COLS="6" OPTS="L2,nj,p7,7/8,i1" CDEF="xs72,12,r50,r50,r50,9"> <TTITLE>Table 1—Original And Supplemental Applications Approved During April, May, and June 2025</TTITLE> <CHED H="1">Date of approval</CHED> <CHED H="1">Application No.</CHED> <CHED H="1"> Sponsor (drug labeler code  <ENT>Bimeda Animal Health Ltd. (061133)</ENT> <ENT>MOXICLOPRID for Cats (imidacloprid and moxidectin) Topical Solution</ENT> <ENT>Original approval as a generic copy of NADA 141-254</ENT> <ENT>524.1146</ENT> <ENT>Hikma Pharmaceuticals USA, Inc. (086194)</ENT> <ENT>Enrofloxacin Flavored Tablets (enrofloxacin flavored tablets)</ENT> <ENT>Original approval as a generic copy of NADA 140-441</ENT> <ENT> 520.812 </ENT> </ROW> <ROW> <ENT I="01">April 3, 2025</ENT> <ENT>200-791</ENT> <ENT>Cronus Pharmaceuticals Specialities India Private Ltd. (069043)</ENT> <ENT>FLUNINE-S (flunixin meglumine injection) Injectable Solution</ENT> <ENT>Original approval as a generic copy of NADA 101-479</ENT> <ENT>522.970</ENT> </ROW> <ROW> <ENT I="01">April 7, 2025</ENT> <ENT>141-586</ENT> <ENT>Phibro Animal Health Corp. (066104)</ENT> <ENT>V-MAX (virginiamycin), RUMENSIN (monensin), and EXPERIOR (lubabegron) Type A medicated articles to be used in the manufacture of Type B and Type C medicated cattle feed</ENT> <ENT>Original approval</ENT> <ENT>558.635</ENT> </ROW> <ROW> <ENT I="01">April 7, 2025</ENT> <ENT>141-588</ENT> <ENT>Phibro Animal Health Corp. (066104)</ENT> <ENT>V-MAX (virginiamycin) and RUMENSIN (monensin) Type A medicated articles to be used in the manufacture of Type B/C medicated cattle feeds</ENT> <ENT>Original approval</ENT> <ENT>558.635</ENT> </ROW> <ROW> <ENT I="01">April 8, 2025</ENT> <ENT>141-587</ENT> <ENT>Phibro Animal Health Corp. (066104)</ENT> <ENT>V-MAX (virginiamycin), RUMENSIN (monensin), and OPTAFLEXX (ractopamine hydrochloride) Type A medicated articles to be used in the manufacture of Type B/C medicated cattle feeds</ENT> <ENT>Original approval</ENT> <ENT>558.635</ENT> </ROW> <ROW> <ENT I="01">April 8, 2025</ENT> <ENT>141-521</ENT> <ENT>Zoetis Inc (054771)</ENT> <ENT>SIMPARICA TRIO (sarolaner, moxidectin, and pyrantel chewable tablets) Chewable Tablets</ENT> <ENT>Supplemental approval</ENT> <ENT>520.2090</ENT> </ROW> <ROW> <ENT I="01">April 10, 2025</ENT> <ENT>141-598</ENT> <ENT>Dechra Ltd. (043264)</ENT> <ENT>OTISERENE (marbofloxacin terbinafine dexamethasone otic suspension)</ENT> <ENT>Original approval</ENT> <ENT>524.1312</ENT> </ROW> <ROW> <ENT I="01">April 23, 2025</ENT> <ENT>141-554</ENT> <ENT>Boehringer Ingelheim Animal Health USA, Inc.(000010)</ENT> <ENT>NEXGARD PLUS (afoxolaner, moxidectin, and pyrantel chewable tablets)</ENT> <ENT>Supplemental approval</ENT> <ENT>520.35</ENT> </ROW> <ROW> <ENT I="01">April 24, 2025</ENT> <ENT>200-797</ENT> <ENT> Huvepharma EOOD <ENT>COXIDIN (monensin) and BMD (bacitracin methylenedisalicylate) Type A medicated articles to be used in the manufacture of Type C medicated broiler feeds</ENT> <ENT>Original approval as a generic copy of NADA 049-463</ENT> <ENT>558.355</ENT> </ROW> <ROW> <ENT I="01">April 24, 2025</ENT> <ENT>200-798</ENT> <ENT>Huvepharma EOOD (016592)</ENT> <ENT>COXIDIN (monensin) and FLAVOMYCIN (bambermycins) Type A medicated articles to be used in the manufacture of Type C medicated broiler feeds</ENT> <ENT>Original approval as a generic copy of NADA 098-340</ENT> <ENT>558.355</ENT> </ROW> <ROW> <ENT I="01">April 24, 2025</ENT> <ENT>200-799</ENT> <ENT>Huvepharma EOOD (016592)</ENT> <ENT>COXIDIN (monensin) and BMD (bacitracin methylenedisalicylate) Type A medicated articles to be used in the manufacture of Type C medicated turkey feeds</ENT> <ENT>Original approval as a generic copy of NADA 140-937</ENT> <ENT>558.355</ENT> </ROW> <ROW> <ENT I="01">April 24, 2025</ENT> <ENT>200-800</ENT> <ENT>Huvepharma EOOD (016592)</ENT> <ENT>COXIDIN (monensin) and FLAVOMYCIN (bambermycins) Type A medicated articles to be used in the manufacture of Type C medicated turkey feeds</ENT> <ENT>Original approval as a generic copy of NADA 140-955</ENT> <ENT>558.355</ENT> </ROW> <ROW> <ENT I="01">April 24, 2025</ENT> <ENT>200-801</ENT> <ENT>Huvepharma EOOD (016592)</ENT> <ENT>COXIDIN (monensin) and INTEPRITY (avilamycin) Type A medicated articles to be used in the manufacture of Type C medicated broiler feeds</ENT> <ENT>Original approval as a generic copy of NADA 141-465</ENT> <ENT>558.68</ENT> </ROW> <ROW> <ENT I="01">April 24, 2025</ENT> <ENT>200-802</ENT> <ENT>Huvepharma EOOD (016592)</ENT> <ENT>COXIDIN (monensin) and PENNITRACIN MD (bacitracin methylenedisalicylate) Type A medicated articles to be used in the manufacture of Type C medicated turkey feeds</ENT> <ENT>Original approval as a generic copy of NADA 141-540</ENT> <ENT>558.355</ENT> </ROW> <ROW> <ENT I="01">April 29, 2025</ENT> <ENT>141-609</ENT> <ENT>Genus plc (086205)</ENT> <ENT>DELETION OF EXON 7 OF CD163 GENE IN DOMESTIC PIGS (Deletion of exon 7 of CD163 gene in domestic pigs)</ENT> <ENT>Original approval</ENT> <ENT>528.2000</ENT> </ROW> <ROW> <ENT I="01">April 29, 2025</ENT> <ENT>141-600</ENT> <ENT>Intervet (000061)</ENT> <ENT>MOMETAMAX SINGLE (gentamicin, posaconazole, and mometasone furoate otic suspension)</ENT> <ENT>Original approval </ENT> <ENT>524.1044j </ENT> </ROW> <ROW> <ENT I="01">May 21, 2025</ENT> <ENT>141-581</ENT> <ENT>Elanco US Inc. (058198)</ENT> <ENT>CREDELIO QUATTRO (lotilaner, moxidectin, praziquantel, and pyrantel)</ENT> <ENT>Supplemental approval</ENT> <ENT>520.1287</ENT> </ROW> <ROW> <ENT I="01">June 24, 2025</ENT> <ENT>200-812</ENT> <ENT>Qilu Animal Health Products Co., Ltd. (086163)</ENT> <ENT>Cefovecin Sodium for Injection (cefovecin sodium)</ENT> <ENT>Original approval as a generic copy of NADA 141-285</ENT> <ENT>522.311</ENT> </ROW> <ROW> <ENT I="01">June 27, 2025</ENT> <ENT>200-813</ENT> <ENT>Felix Pharmaceuticals Pvt. Ltd. (086101)</ENT> <ENT>Clindamycin Hydrochloride Tablets (clindamycin hydrochloride)</ENT> <ENT>Original approval as a generic copy of NADA 120-161</ENT> <ENT>520.446</ENT> </ROW> <ROW> <ENT I="01">June 27, 2025</ENT> <ENT>200-814</ENT> <ENT>Felix Pharmaceuticals Pvt. Ltd. (086101)</ENT> <ENT>Methimazole Coated Tablets (methimazole tablets)</ENT> <ENT>Original approval as a generic copy of NADA 141-292</ENT> <ENT>520.1375</ENT> </ROW> <TNOTE> <SU>1</SU>  See 21 CFR 510.600(c) for sponsor addresses. </TNOTE> <TNOTE> <SU>2</SU>  Approved in the first quarter of 2025. </TNOTE> <TNOTE> <SU>3</SU>  Ibid. </TNOTE> </GPOTABLE> <HD SOURCE="HD1">II. Withdrawal of Approval of Applications</HD> Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom (drug labeler code 043264) requested that FDA withdraw approval of one NADA listed in table 2 because the product was never manufactured or marketed. Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211 (drug labeler code 017033) requested that FDA withdraw approval of two ANADAs listed in table 2 because the products are no longer manufactured or marketed. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these actions. <GPOTABLE COLS="4" OPTS="L2,nj,i1" CDEF="xs72,12,r50,9"> <TTITLE>Table 2—Applications for Which Approval Was Voluntarily Withdrawn During April, May, and June 2025</TTITLE> <CHED H="1">Date of withdrawal of approval</CHED> <CHED H="1">Application No.</CHED> <CHED H="1">Product name</CHED> <CHED H="1">21 CFR section</CHED> <ROW> <ENT I="01">May 27, 2025</ENT> <ENT>008-760</ENT> <ENT>ADRENOMONE (corticotropin) Injectable Solution</ENT> <ENT>522.480</ENT> </ROW> <ROW> <ENT I="01">Do</ENT> <ENT>200-366</ENT> <ENT>Carprofen Caplets (carprofen)</ENT> <ENT>520.304</ENT> </ROW> <ROW> <ENT I="01">Do</ENT> <ENT>200-575</ENT> <ENT>Carprofen Chewable Tablets (carprofen)</ENT> <ENT>520.304</ENT> </ROW> </GPOTABLE> <HD SOURCE="HD1">III. C ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 42k characters. 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