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, 529, and 558</CFR> <DEPDOC>[Docket No. FDA-2024-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 October, November, and December 2024. 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 January 21, 2025. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> George K. Haibel, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-5689, <E T="03">george.haibel@fda.hhs.gov</E> . </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Approval of New Animal Drug Applications</HD> FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during October, November, and December 2024, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOIA Summaries) under the Freedom of Information Act (FOIA). These documents, along with marketing exclusivity and patent information, may be obtained 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="s50,12,r50,r100,r100,12"> <TTITLE>Table 1—Original and Supplemental NADAs and ANADAs Approved During October, November, and December 2024 Requiring Evidence of Safety and/or Effectiveness</TTITLE> <CHED H="1">Date of approval</CHED> <CHED H="1">File No.</CHED> <CHED H="1"> Sponsor (drug labeler code  <ENT O="xl">Boehringer Ingelheim Animal Health USA, Inc. (000010)</ENT> <ENT>NEXGARD PLUS (afoxolaner, moxidectin, and pyrantel chewable tablets)</ENT> <ENT>Supplemental approval for the treatment and control of Asian longhorned tick infestations for 1 month in dogs and puppies</ENT> <ENT>520.35</ENT> </ROW> <ROW> <ENT I="01">October 7, 2024</ENT> <ENT>141-581</ENT> <ENT O="xl">Elanco US Inc. (058198)</ENT> <ENT>CREDELIO QUATTRO (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets</ENT> <ENT>Original approval for the prevention of heartworm disease and for the treatment and control of roundworm, hookworm, and tapeworm infections. Kills adult fleas and is indicated for the treatment and prevention of flea infestations and the treatment and control of tick infestations for 1 month in dogs and puppies</ENT> <ENT>520.1287</ENT> </ROW> <ROW> <ENT I="01">October 18, 2024</ENT> <ENT>200-748</ENT> <ENT O="xl">Huvepharma EOOD (016592)</ENT> <ENT>PENNCHLOR (chlortetracycline Type A medicated article) and MONOVET (monensin) Type A medicated article) to be used in the manufacture of Type B and Type C medicated feeds</ENT> <ENT>Original approval as a generic copy of NADA 141-564</ENT> <ENT>558.128</ENT> </ROW> <ROW> <ENT I="01">October 23, 2024</ENT> <ENT>141-589</ENT> <ENT O="xl">Elanco US Inc. (058198)</ENT> <ENT>EXPERIOR (lubabegron Type A medicated article) and MGA (melengestrol acetate Type A medicated article) to be used in the manufacture of Type C medicated feeds</ENT> <ENT>Original approval for increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), and for reduction of ammonia gas emissions per pound of live weight and hot carcass weight in growing beef heifers fed in confinement for slaughter during the last 14 to 91 days on feed</ENT> <ENT>558.330</ENT> </ROW> <ROW> <ENT I="01">October 25, 2024</ENT> <ENT>141-590</ENT> <ENT O="xl">Do.</ENT> <ENT>EXPERIOR (lubabegron Type A medicated article), RUMENSIN (monensin Type A medicated article), and MGA (melengestrol acetate Type A medicated article) to be used in the manufacture of Type C medicated feeds</ENT> <ENT> Original approval for increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), for reduction of ammonia gas emissions per pound of live weight and hot carcass weight, and for the prevention and control of coccidiosis caused by <E T="03">Eimeria bovis</E> and <E T="03">Eimeria zuernii</E> in growing beef heifers fed in confinement for slaughter during the last 14 to 91 days on feed </ENT> <ENT>558.330</ENT> </ROW> <ROW> <ENT I="01">October 25, 2024</ENT> <ENT>141-591</ENT> <ENT O="xl">Do.</ENT> <ENT>EXPERIOR (lubabegron Type A medicated article), RUMENSIN (monensin Type A medicated article), TYLAN (tylosin Type A medicated article), and MGA (melengestrol acetate Type A medicated article) to be used in the manufacture of Type C medicated feeds</ENT> <ENT> Original approval for increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), for reduction of ammonia gas emissions per pound of live weight and hot carcass weight, and for the prevention and control of coccidiosis caused by <E T="03">Eimeria bovis</E> and <E T="03">Eimeria zuernii</E> and for reduction of incidence of liver abscesses associated with <E T="03">Fusobacterium necrophorum</E> and <E T="03">Arcanobacterium pyogenes</E> in growing beef heifers fed in confinement for slaughter during the last 14 to 91 days on feed </ENT> <ENT>558.625</ENT> </ROW> <ROW> <ENT I="01">November 6, 2024</ENT> <ENT>141-521</ENT> <ENT O="xl">Zoetis Inc. (054771)</ENT> <ENT>SIMPARICA TRIO (sarolaner, moxidectin, and pyrantel chewable tablets)</ENT> <ENT>Supplemental approval for the treatment and control of tick infestations with Asian longhorned tick for 1 month in dogs and puppies</ENT> <ENT>520.2090</ENT> </ROW> <ROW> <ENT I="01">November 13, 2024</ENT> <ENT>141-502</ENT> <ENT>Do.</ENT> <ENT>REVOLUTION PLUS (selamectin and sarolaner topical solution)</ENT> <ENT>Supplemental approval for the prevention of tapeworm infections as a direct result of killing vector fleas on the treated cat for 1 month in cats and kittens</ENT> <ENT>524.2099</ENT> </ROW> <ROW> <ENT I="01">November 14, 2024</ENT> <ENT>200-803</ENT> <ENT O="xl">Phibro Animal Health Corp. (066104)</ENT> <ENT>PAQFLOR (florfenicol) Type A Medicated Article to be used in the manufacture of Type C medicated feeds</ENT> <ENT>Original approval as a generic copy of NADA 141-246</ENT> <ENT>558.261</ENT> </ROW> <ROW> <ENT I="01">November 18, 2024</ENT> <ENT>200-793</ENT> <ENT O="xl">Parnell Technologies, Pty., Ltd. (068504)</ENT> <ENT>PROPOFOLVET MULTIDOSE (propofol injectable emulsion)</ENT> <ENT>Original approval as a generic copy of NADA 141-098</ENT> <ENT>522.2005</ENT> </ROW> <ROW> <ENT I="01">November 18, 2024</ENT> <ENT>200-805</ENT> <ENT O="xl">Virbac AH, Inc. (051311)</ENT> <ENT>MEL 500 (melengestrol acetate Type A liquid medicated article) to be used in the manufacture of Type C medicated feeds</ENT> <ENT>Original approval as a generic copy of NADA 039-402</ENT> <ENT>558.342</ENT> </ROW> <ROW> <ENT I="01">November 20, 2024</ENT> <ENT>200-636</ENT> <ENT O="xl">Bimeda Animal Health, Ltd. (061133)</ENT> <ENT>DORACIDE (doramectin topical solution)</ENT> <ENT>Original approval as a generic copy of NADA 141-095</ENT> <ENT>524.770</ENT> </ROW> <ROW> <ENT I="01">November 22, 2024</ENT> <ENT>141-452</ENT> <ENT O="xl">Zoetis Inc. (054771)</ENT> <ENT>SIMPARICA (sarolaner) Chewable Tablet</ENT> <ENT>Supplemental approval for the treatment and control of tick infestations with Asian longhorned tick for 1 month in dogs and puppies</ENT> <ENT>520.2086</ENT> </ROW> <ROW> <ENT I="01">November 25, 2024</ENT> <ENT>141-532</ENT> <ENT O="xl">Intervet, Inc. (000061)</ENT> <ENT>BRAVECTO 1-MONTH (fluralaner) Chewable Tablet</ENT> <ENT>Supplemental approval for the treatment and control of Asian longhorned tick infestations for 1 month in dogs and puppies</ENT> <ENT>520.998</ENT> </ROW> <ROW> <ENT I="01">December 19, 2024</ENT> <ENT>141-043</ENT> <ENT O="xl">Zoetis Inc. (054771)</ENT> <ENT>SYNOVEX CHOICE and SYNOVEX PRIMER (trenbolone acetate and estradiol benzoate implants) Implants</ENT> <ENT>Supplemental approval of both products for increased rate of weight gain in growing beef steers and heifers on pasture (stocker, feeder, and slaughter)</ENT> <ENT>522.2478</ENT> </ROW> <TNOTE> <SU>1</SU>  See § 510.600(c) (21 CFR 510.600(c)) for sponsor addresses. </TNOTE> </GPOTABLE> <HD SOURCE="HD1">II. Withdrawal of Approval of New Animal Drug Applications</HD> Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767-1861 (drug labeler code (054925) requested that FDA withdraw approval of NADA 140-810 for DERMA-VET (nystatin, neomycin sulfate, thiostrepton, triamcinolone acetonide) Ointment because the product is no longer manufactured or marketed. Accordingly, approval of NADA 140-810 was withdrawn effective December 23, 2024. The animal drug regulations do not require amendment as the sponsor's drug labeler code is not codified in 21 CFR 524.1600a. Mylan Institutional LLC, a Viatris Company, 3711 Collins Ferry Rd., Morgantown, WV 26505 (drug labeler code 063286) requested that FDA withdraw approval of ANADA 200-257 for Ketamine HCL (ketamine hydrochloride injection, USP) Injectable Solution because th ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 45k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━