New Animal Drugs; 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, 516, 520, 522, 524, 529, 556, and 558</CFR> <DEPDOC>[Docket No. FDA-2024-N-0002]</DEPDOC> <SUBJECT>New Animal Drugs; 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), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during April, May, and June 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 October 28, 2024. </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. Approvals</HD> FDA is amending the animal drug regulations to reflect approval actions for NADAs, ANADAs, and CNADAs during April, May, and June 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="xs60,8,r50,r50,r50,9"> <TTITLE>Table 1—Original and Supplemental NADAs, ANADAs, and CNADAs Approved During April, May, and June 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) </CHED> <CHED H="1">Product name</CHED> <CHED H="1">Effect of the action</CHED> <ENT>Zoetis Inc, 333 Portage St., Kalamazoo, MI 49007 (054771)</ENT> <ENT>SYNOVEX CHOICE (trenbolone acetate and estradiol benzoate) and SYNOVEX PRIMER (trenbolone acetate and estradiol benzoate)</ENT> <ENT>Supplemental approval for increased rate of weight gain in growing beef steers and heifers in a dry lot</ENT> <ENT>522.2478</ENT> </ROW> <ROW> <ENT I="01">April 9, 2024</ENT> <ENT>141-550</ENT> <ENT>Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 (058198)</ENT> <ENT>PRADALEX (pradofloxacin injection)</ENT> <ENT>Original approval for treatment of bovine respiratory disease and swine respiratory disease</ENT> <ENT> 522.1860 556.530 </ENT> </ROW> <ROW> <ENT I="01">April 10, 2024</ENT> <ENT>200-777</ENT> <ENT>Felix Pharmaceuticals PVT Ltd., 25-28 North Wall Quay, Dublin 1, Ireland (086101)</ENT> <ENT>Carprofen Injectable Solution</ENT> <ENT>Original approval as a generic copy of NADA 141-199</ENT> <ENT>522.304</ENT> </ROW> <ROW> <ENT I="01">April 25, 2024</ENT> <ENT>200-728</ENT> <ENT>Cronus Pharma Specialties India Private Ltd., Plot No. 9(B), Survey No. 99/1, GMR Hyderabad Aviation SEZ Ltd., Mamidipalle Village, Balapur Mandal, Shamshabad, Rangareddy, Hyderabad, Telangana, 500108, India (069043)</ENT> <ENT>PIMOMEDIN (pimobendan) Tablets</ENT> <ENT>Original approval as a generic copy of NADA 141-033</ENT> <ENT>520.1780</ENT> </ROW> <ROW> <ENT I="01">April 26, 2024</ENT> <ENT>141-582</ENT> <ENT>Warburton Technology Ltd., 36 Fitzwilliam Square, Dublin, Dublin, D02HX82, Ireland (066679)</ENT> <ENT>MULTIMIN 90 (zinc, copper, manganese, and selenium injection)</ENT> <ENT>Original approval as a supplemental source of zinc, copper, manganese, and selenium in cattle</ENT> <ENT>522.2694</ENT> </ROW> <ROW> <ENT I="01">May 8, 2024</ENT> <ENT>200-780</ENT> <ENT>Aurora Pharmaceutical, Inc., 1196 Highway 3 South, Northfield, MN 55057-3009 (051072)</ENT> <ENT>COCCIAID (amprolium) for Calves</ENT> <ENT>Original approval as a generic copy of NADA 013-149</ENT> <ENT>520.100</ENT> </ROW> <ROW> <ENT I="01">May 9, 2024</ENT> <ENT>200-782</ENT> <ENT>Cronus Pharma Specialties India Private Ltd., Plot No. 9(B), Survey No. 99/1, GMR Hyderabad Aviation SEZ Ltd., Mamidipalle Village, Balapur Mandal, Shamshabad, Rangareddy, Hyderabad, Telangana, 500108, India (069043)</ENT> <ENT>ENROPRO Silver Otic (enrofloxacin/silver sulfadiazine) Otic Emulsion</ENT> <ENT>Original approval as a generic copy of NADA 141-176</ENT> <ENT>524.802</ENT> </ROW> <ROW> <ENT I="01">May 10, 2024</ENT> <ENT>141-577</ENT> <ENT>Vetoquinol USA, Inc., 4250 N Sylvania Ave., Fort Worth, TX 76137 (017030)</ENT> <ENT>UPCARD-CA1 (torsemide oral solution)</ENT> <ENT>Conditional approval as concurrent therapy with pimobendan, spironolactone, and an angiotensin converting enzyme (ACE) inhibitor for the management of pulmonary edema in dogs with congestive heart failure caused by myxomatous mitral valve disease (MMVD)</ENT> <ENT>516.2475</ENT> </ROW> <ROW> <ENT I="01">May 16, 2024</ENT> <ENT>200-781</ENT> <ENT>Cronus Pharma Specialties India Private Ltd., Plot No. 9(B), Survey No. 99/1, GMR Hyderabad Aviation SEZ Ltd., Mamidipalle Village, Balapur Mandal, Shamshabad, Rangareddy, Hyderabad, Telangana, 500108, India (069043)</ENT> <ENT>FLUNINE (flunixin meglumine injection)</ENT> <ENT>Original approval as a generic copy of NADA 101-479</ENT> <ENT>522.970</ENT> </ROW> <ROW> <ENT I="01">May 23, 2024</ENT> <ENT>131-675</ENT> <ENT>Intervet, Inc., 126 E Lincoln Ave., Rahway, NJ 07065 (000061)</ENT> <ENT>SAFE-GUARD 20% (fenbendazole) Type A medicated article</ENT> <ENT> Supplemental approval for the treatment and control of cecal worms ( <E T="03">Aulonocephalus</E> spp.) in wild quail </ENT> <ENT>558.258</ENT> </ROW> <ROW> <ENT I="01">June 4, 2024</ENT> <ENT>138-255</ENT> <ENT>Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215 (058005)</ENT> <ENT>Iron Dextran 20% Injection (iron hydrogenated dextran injection) Injectable Solution</ENT> <ENT>Supplemental approval for the prevention or treatment of iron deficiency anemia in nursing piglets</ENT> <ENT>522.1182</ENT> </ROW> <ROW> <ENT I="01">June 11, 2024</ENT> <ENT>200-787</ENT> <ENT>ZyVet Animal Health, Inc., 73 Route 31N, Pennington, NJ 08534 (086117)</ENT> <ENT>Phenylpropanolamine Hydrochloride Chewable Tablets</ENT> <ENT>Original approval for the control of urinary incontinence due to urethral sphincter hypotonus in dogs as a generic copy of NADA 141-324</ENT> <ENT>520.1760</ENT> </ROW> <ROW> <ENT I="01">June 17, 2024</ENT> <ENT>200-785</ENT> <ENT>Felix Pharmaceuticals PVT Ltd., 25-28 North Wall Quay, Dublin 1, IRELAND</ENT> <ENT>Maropitant Citrate Tablets (maropitant citrate)</ENT> <ENT>Original approval as a generic copy of NADA 141-262</ENT> <ENT>520.1315</ENT> </ROW> <ROW> <ENT I="01">June 20, 2024</ENT> <ENT>200-784</ENT> <ENT>ZyVet Animal Health, Inc., 73 Route 31N, Pennington, NJ 08534 (086117)</ENT> <ENT>Trimeprazine with prednisolone tablets</ENT> <ENT>Original approval as a generic copy of NADA 012-437</ENT> <ENT>520.2604</ENT> </ROW> </GPOTABLE> <HD SOURCE="HD1">II. Change of Sponsor</HD> Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 has informed FDA that it has transferred ownership of, and all rights and interest in, ANADA 200-582 for LONCOR 300 (florfenicol) Injectable Solution to Zoetis Inc, 333 Portage St., Kalamazoo, MI 49007. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect this action. <HD SOURCE="HD1">III. Change of Sponsor Address</HD> Ivaoes Animal Health (drug labeler code 086064 in 21 CFR 510.600(c)) has informed FDA that it has changed its address to 2101 W Atlantic Blvd., Suite 108, Pompano Beach, FL 33069. The entries in § 510.600(c) are amended to reflect this action. <HD SOURCE="HD1">IV. Technical Amendments</HD> FDA is making the following amendments to improve the accuracy and readability of the animal drug regulations. • 21 CFR 510.600 is amended to revise the entries for Ivaoes Animal Health Inc. in the lists of sponsors of approved applications and to add entries for Warburton Technology Ltd. • 21 CFR 516.1760 is being amended to provide for additional strengths of phenobarbital tablets. • 21 CFR 520.2130 is amended to revise body weights of dogs and cats for treatment with spinosad chewable tablets. • 21 CFR 520.2598 is being amended to reflect an additional strength trilostane capsule. • 21 CFR 522.772 is amended to revise specific parasite indications and to reflect the prescription marketing status of doramectin and levamisole injectable solution for use in cattle. • 21 CFR 522.970 is amended to reflect approved food-producing animal species for separate sponsor products. • 21 CFR 522.1696b is amended to revise the preslaughter withdrawal period for cattle administered a penicillin G procaine aqueous suspension. • 21 CFR 529.1004 is amended to reflect approved conditions of use for formalin in finfish. • 21 CFR 529.1150 is amended to reflect approved conditions of use for hydrogen peroxide in freshwater-reared salmonids. • 21 CFR 556.275 is amended by adding a tolerance for residues of fenbendazole in edible tissues of quail established as a consequence of the supplemental approval of fenbendazole medicated quail feed. • 21 CFR 556.530 is added to provide tolerances for ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 40k characters. 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