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

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Parts 516, 520, 522, 529, 556, 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 Application; 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), 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. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> This rule is effective February 6, 2026. </DATES> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Cathie Marshall, Center for Veterinary Medicine, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, <E T="03">cathie.marshall@fda.hhs.gov,</E> 240-402-5693. </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, 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: <E T="03">https://animaldrugsatfda.fda.gov/adafda/views/#/search</E> . <GPOTABLE COLS="6" OPTS="L2,nj,p7,7/8,i1" CDEF="xs72,11,r50,r75,r50,8"> <TTITLE>Table 1—Original, Conditional, and Supplemental Applications Approved During July, August, and September 2025</TTITLE> <CHED H="1">Date of approval</CHED> <CHED H="1"> Application No. </CHED> <CHED H="1"> Sponsor (drug labeler code  <ENT>MGA (melengestrol acetate Type A medicated article) and EXPERIOR (lubabegron Type A medicated article) and MONOVET (monensin Type A medicated article)</ENT> <ENT>Original approval as a generic copy of NADA 141-590</ENT> <ENT>558.330</ENT> </ROW> <ROW> <ENT I="01">July 8, 2025</ENT> <ENT>200-808</ENT> <ENT>Huvepharma EOOD (016592)</ENT> <ENT>MGA (melengestrol acetate Type A medicated article) and EXPERIOR (lubabegron Type A medicated article) and MONOVET (monensin Type A medicated article) and TYLOVET (tylosin phosphate Type A medicated article)</ENT> <ENT>Original approval as a generic copy of NADA 141-591</ENT> <ENT>558.625</ENT> </ROW> <ROW> <ENT I="01">July 8, 2025</ENT> <ENT>200-815</ENT> <ENT>Felix Pharmaceuticals Pvt. Ltd. (086101)</ENT> <ENT>Cefpodoxime Proxetil Tablets (cefpodoxime proxetil tablets)</ENT> <ENT>Original approval as a generic copy of NADA 141-232</ENT> <ENT>520.370</ENT> </ROW> <ROW> <ENT I="01">July 10, 2025</ENT> <ENT>141-599</ENT> <ENT>Intervet, Inc. (000061)</ENT> <ENT>BRAVECTO QUANTUM (fluralaner for extended-release injectable suspension)</ENT> <ENT>Original approval</ENT> <ENT>522.998</ENT> </ROW> <ROW> <ENT I="01">July 11, 2025</ENT> <ENT>200-816</ENT> <ENT>Cronus Pharma Specialities India Private Ltd. (069043)</ENT> <ENT>Meloxisol (meloxicam oral suspension 1.5 mg/mL)</ENT> <ENT>Original approval as a generic copy of NADA 141-213</ENT> <ENT>520.1367</ENT> </ROW> <ROW> <ENT I="01">July 17, 2025</ENT> <ENT>141-607</ENT> <ENT>Intervet, Inc. (000061)</ENT> <ENT>EXZOLT (fluralaner oral solution)</ENT> <ENT>Original approval</ENT> <ENT> 520.999 556.290 </ENT> </ROW> <ROW> <ENT I="01">July 18, 2025</ENT> <ENT>200-759</ENT> <ENT>ZyVet Animal Health, Inc. (086117)</ENT> <ENT>Furosemide Tablets (furosemide tablets)</ENT> <ENT>Original approval as a generic copy of NADA 034-621</ENT> <ENT>520.1010</ENT> </ROW> <ROW> <ENT I="01">July 21, 2025</ENT> <ENT>200-817</ENT> <ENT>Felix Pharmaceuticals Pvt. Ltd. (086101)</ENT> <ENT>Meloxicam Oral Suspension (meloxicam oral suspension 1.5mg/mL)</ENT> <ENT>Original approval as a generic copy of NADA 141-213</ENT> <ENT>520.1367</ENT> </ROW> <ROW> <ENT I="01">August 5, 2025</ENT> <ENT>200-818</ENT> <ENT>Bimeda Animal Health Ltd. (061133)</ENT> <ENT>MOXICLOPRID for dogs (imidacloprid and moxidectin)</ENT> <ENT>Original approval as a generic copy of NADA (141-251)</ENT> <ENT>524-1146</ENT> </ROW> <ROW> <ENT I="01">August 14, 2025</ENT> <ENT>200-794</ENT> <ENT>Cronus Pharma Specialities India Private Ltd. (069043)</ENT> <ENT>MELOXISOL (meloxicam oral suspension 0.5mg/mL)</ENT> <ENT>Original approval as a generic copy of NADA 141-213</ENT> <ENT>520.1367</ENT> </ROW> <ROW> <ENT I="01">August 28, 2025</ENT> <ENT>200-821</ENT> <ENT>Parnell Technologies Pty. Ltd. (068504)</ENT> <ENT>Isoflurane (isoflurane liquid)</ENT> <ENT>Original approval as a generic copy of NADA 135-773</ENT> <ENT>529.1186</ENT> </ROW> <ROW> <ENT I="01">August 28, 2025</ENT> <ENT>200-819</ENT> <ENT>Bimeda Animal Health Ltd. (061133)</ENT> <ENT>GAMROZYNE (gamithromycin)</ENT> <ENT>Original approval as a generic copy of NADA 141-328</ENT> <ENT>522.1014</ENT> </ROW> <ROW> <ENT I="01">September 19, 2025</ENT> <ENT>200-824</ENT> <ENT>Felix Pharmaceuticals Pvt. Ltd. (086101)</ENT> <ENT>Dexmedetomidine (dexmedetomidine hydrochloride sterile injectable solution)</ENT> <ENT>Original approval as a generic copy of NADA 141-267</ENT> <ENT>522.558</ENT> </ROW> <ROW> <ENT I="01">September 30, 2025</ENT> <ENT>141-616</ENT> <ENT>Zoetis Inc., (054771)</ENT> <ENT>DECTOMAX-CA1 (doramectin injectable solution)</ENT> <ENT>Conditional approval</ENT> <ENT>516.570</ENT> </ROW> <TNOTE> <SU>1</SU>  See 21 CFR 510.600(c) for sponsor addresses. </TNOTE> </GPOTABLE> <HD SOURCE="HD1">II. Withdrawal of Approval of Applications</HD> 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. <GPOTABLE COLS="4" OPTS="L2,nj,i1" CDEF="xs72,11,r50,8"> <TTITLE>Table 2—Applications for Which Approval Was Voluntarily Withdrawn During July, August, and September 2025</TTITLE> <CHED H="1">Date of withdrawal of approval</CHED> <CHED H="1"> Application No. </CHED> <CHED H="1">Product name</CHED> <ENT>HYGROMIX 2.5 (hygromycin B Type A medicated article)</ENT> <ENT>558.274</ENT> </ROW> <TNOTE> <SU>1</SU>  This withdrawal was not previously published. </TNOTE> </GPOTABLE> <HD SOURCE="HD1">III. Changes of Sponsor</HD> 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. <GPOTABLE COLS="5" OPTS="L2,nj,p7,7/8,i1" CDEF="xs50,r100,r50,r50,8"> <TTITLE>Table 3—Applications for Which Ownership Was Transferred to Another Sponsor During July, August, and September 2025</TTITLE> <CHED H="1">Application No.</CHED> <CHED H="1">Product name</CHED> <CHED H="1"> Transferring sponsor (drug labeler code) </CHED> <CHED H="1"> New sponsor (drug labeler code) <ENT>BIO-COX (salinomycin sodium Type A medicated article) and BMD (bacitracin methylenedisalicylate Type A medicated article)</ENT> <ENT>Zoetis Inc. (054771)</ENT> <ENT>Phibro Animal Health Corp. (066104)</ENT> <ENT>558.550</ENT> </ROW> <ROW> <ENT I="01">091-749</ENT> <ENT>TYLAN 10 SULFA-G and TYLAN 40 SULFA-G (tylosin phosphate Type A medicated article and sulfamethazine Type A medicated article)</ENT> <ENT>Do</ENT> <ENT>Do</ENT> <ENT>558.630</ENT> </ROW> </GPOTABLE> <HD SOURCE="HD1">IV. Legal Authority</HD> 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. <LSTSUB> <HD SOURCE="HED">List of Subjects</HD> <CFR>21 CFR Part 516</CFR> Administrative practice and procedure, Animal drugs, Confidential business information, Reporting and recordkeeping requirements. <CFR>21 CFR Parts 520, 522, and 529</CFR> Animal drugs. <CFR>21 CFR Part 556</CFR> Animal drugs, Dairy products, Foods, Meat and meat products. <CFR>21 CFR Part 558</CFR> Animal drugs, Animal feeds. </LSTSUB> 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: <HD SOURCE="HED">PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES</HD> <REGTEXT TITLE="21" PART="516"> 1. The authority citation for part 516 continues to read as follows: <HD SOURCE="HED">Authority: </HD> 21 U.S.C. 360ccc-1, 360ccc-2, 371. </REGTEXT> <REGTEXT TITLE="21" PART="516"> 2. Add § 516.570 to read as follows: <SECTION> <SECTNO>§ 516.570</SECTNO> <SUBJECT>Doramectin.</SUBJECT> (a) <E T="03">Specifications.</E> Each milliliter of solution contains 10 milligrams of doramectin. (b) <E T="03">Sponsor.</E> See No. 054771 in § 510.600(c) of this chapter. (c) <E T="03">Conditions of use in cattle</E> —(1) <E T="03">Amount.</E> 200 micrograms per kilogr ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 27k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━