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, 556, and 558</CFR> <DEPDOC>[Docket No. FDA-2023-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 2023. 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 February 27, 2024. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> George K. Haibel, Center for Veterinary Medicine (HFV-6), 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 and ANADAs during October, November, and December 2023, 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="xs80,8,r50,r50,r50,8"> <TTITLE>Table 1—Original and Supplemental NADAs and ANADAs Approved During October, November, and December 2023 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> <ENT>Virbac AH, Inc., P.O. Box 162059, Fort Worth, TX 76161 (051311)</ENT> <ENT>AYRADIA (metronidazole) oral solution</ENT> <ENT> Original approval for the treatment of <E T="03">Giardia duodenalis</E> infection in dogs </ENT> <ENT>520.1425</ENT> </ROW> <ROW> <ENT I="01">October 13, 2023</ENT> <ENT>141-336</ENT> <ENT>ECO LLC, 344 Nassau St., Princeton, NJ 08540 (066916)</ENT> <ENT>AIVLOSIN (tylvalosin tartrate) Water Soluble Granules</ENT> <ENT>Supplemental approval adding females intended for breeding to approved classes of swine</ENT> <ENT>520.2645</ENT> </ROW> <ROW> <ENT I="01">October 20, 2023</ENT> <ENT>141-564</ENT> <ENT>Pharmgate Inc., 1800 Sir Tyler Rd., Wilmington, NC 28405 (069254)</ENT> <ENT>PENNCHLOR (chlortetracycline Type A medicated article) and RUMENSIN (monensin Type A medicated article)</ENT> <ENT>Original approval for treatment of bacterial enteritis and pneumonia; and for increased rate of weight gain or prevention and control of coccidiosis in replacement beef and dairy heifers</ENT> <ENT>558.128</ENT> </ROW> <ROW> <ENT I="01">November 8, 2023</ENT> <ENT>200-758</ENT> <ENT>Felix Pharmaceuticals Pvt. Ltd., 25-28 North Wall Quay, Dublin 1, Ireland (086101)</ENT> <ENT>Enrofloxacin Injectable Solution</ENT> <ENT>Original approval for treatment and control of bovine respiratory disease (BRD) in beef cattle and non-lactating dairy cattle and swine respiratory disease (SRD) and control of colibacillosis in groups or pens of weaned pigs, as a generic copy of NADA 141-068</ENT> <ENT>522.812</ENT> </ROW> <ROW> <ENT I="01">November 17, 2023</ENT> <ENT>141-580</ENT> <ENT>Orion Corp., Orionintie 1, 02200 Espoo, Finland (052483)</ENT> <ENT>BONQAT (pregabalin) Oral Solution</ENT> <ENT>Original approval for alleviation of acute anxiety and fear associated with transportation and veterinary visits in cats</ENT> <ENT>520.1892</ENT> </ROW> <ROW> <ENT I="01">December 14, 2023</ENT> <ENT>141-502</ENT> <ENT>Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 (054771)</ENT> <ENT>REVOLUTION PLUS (selamectin and sarolaner topical solution)</ENT> <ENT> Supplemental approval for the treatment and control of tick infestations with <E T="03">Amblyomma americanum</E> (lone star tick) in cats and kittens 8 weeks of age and older, and weighing 2.8 pounds or greater </ENT> <ENT>524.2099</ENT> </ROW> <ROW> <ENT I="01">December 21, 2023</ENT> <ENT>200-760</ENT> <ENT>Cronus Pharma Specialties India Private Ltd., Sy No-99/1, M/s GMR Hyderabad Aviation SEZ Ltd., Mamidipalli Village, Shamshabad Mandal, Ranga Reddy, Hyderabad, Telangana, 501218, India (069043)</ENT> <ENT>FLORFENIJECT (florfenicol) Injectable Solution</ENT> <ENT>Original approval for treatment of bovine respiratory disease (BRD) and bovine interdigital phlegmon; and for the control of respiratory disease in cattle at high risk of developing BRD, as a generic copy of NADA 141-063</ENT> <ENT>522.955</ENT> </ROW> <ROW> <ENT I="01">December 22, 2023</ENT> <ENT>200-762</ENT> <ENT>Do</ENT> <ENT>CAROFENVET (carprofen) Injectable Solution</ENT> <ENT>Original approval for the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries, as a generic copy of NADA 141-199</ENT> <ENT>522.304</ENT> </ROW> <ROW> <ENT I="01">December 22, 2023</ENT> <ENT>200-764</ENT> <ENT>Do</ENT> <ENT>ENROPRO 22.7 (enrofloxacin) Injectable Solution</ENT> <ENT>Original approval for the management of diseases in dogs associated with bacteria susceptible to enrofloxacin, as a generic copy of NADA 140-913</ENT> <ENT>522.812</ENT> </ROW> <ROW> <ENT I="01">December 22, 2023</ENT> <ENT>200-765</ENT> <ENT>Do</ENT> <ENT>ENROPRO 100 (enrofloxacin) Injectable Solution</ENT> <ENT>Original approval for treatment and control of bovine respiratory disease (BRD) in beef cattle and non-lactating dairy cattle and swine respiratory disease (SRD) and control of colibacillosis in groups or pens of weaned pigs, as a generic copy of NADA 141-068</ENT> <ENT>522.812</ENT> </ROW> </GPOTABLE> <HD SOURCE="HD1">II. Withdrawals of Approval</HD> ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115 (drug labeler code 012286) requested that FDA withdraw approval of the four NADAs 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,p7,7/8,i1" CDEF="xs80,8,r100,8"> <TTITLE>Table 2—Applications for Which Approval Was Voluntarily Withdrawn During October, November, and December 2023</TTITLE> <CHED H="1"> Date of withdrawal of approval </CHED> <CHED H="1">File No.</CHED> <CHED H="1">New animal drug</CHED> <ENT>E-Z-EX Wormer Pellets (thiabendazole)</ENT> <ENT>n/a</ENT> </ROW> <ROW> <ENT I="01">Do</ENT> <ENT>042-910</ENT> <ENT>E-Z-EX WORMER MINTRATE Block (thiabendazole) Mineral Protein Block</ENT> <ENT>558.600</ENT> </ROW> <ROW> <ENT I="01">Do</ENT> <ENT>118-877</ENT> <ENT>BAN-A-WORM (pyrantel tartrate) Ton Pack</ENT> <ENT>n/a</ENT> </ROW> <ROW> <ENT I="01">Do</ENT> <ENT>132-448</ENT> <ENT>FLAVOMYCIN (bambermycins) Type A Medicated Article</ENT> <ENT>558.95</ENT> </ROW> </GPOTABLE> <HD SOURCE="HD1">III. Change of Sponsor</HD> The sponsors of the approved applications listed in table 3 have 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="xs35,r50,r50,r50,12"> <TTITLE>Table 3—Applications for Which Ownership Was Transferred to Another Sponsor During October, November, and December 2023</TTITLE> <CHED H="1">File 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>Isoflurane, U.S.P</ENT> <ENT>Piramal Pharma Ltd., Ground Floor, Piramal Ananta, Agastya Corporate Park, Mumbai, Maharashtra, 400070, India (065085)</ENT> <ENT>Piramal Critical Care, Inc., 3850 Schelden Circle, Bethlehem, PA 18017 (066794)</ENT> <ENT>529.1186</ENT> </ROW> <ROW> <ENT I="01">200-576</ENT> <ENT>Gentamicin Sulfate Ophthalmic Solution</ENT> <ENT>Akorn Operating Co. LLC, 5605 Centerpoint Ct., Suite A, Gurnee, IL 60031 (059399)</ENT> <ENT>Domes Pharma S.A., ZAC de Champ Lamet, 3 rue Andre Citroen, Pont-du-Chateau, Auvergne-Rhône-Alpes, 63430, France (086189)</ENT> <ENT>524.1044a</ENT> </ROW> <ROW> <ENT I="01">200-670</ENT> <ENT>SENERGY (selamectin) Topical Solution</ENT> <ENT>Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, County Galway, Ireland (061651)</ENT> <ENT>Virbac AH, Inc., P.O. Box 162059, Fort Worth, TX 76161 (051311)</ENT> <ENT>524.2098</ENT> </ROW> <ROW> <ENT I="01">200-700</ENT> <ENT>PARASEDGE Multi for Dogs (Imidacloprid and moxidectin)</ENT> <ENT>Do</ENT> <ENT>Do</ENT> <ENT>524.1146</ENT> </ROW> <ROW> <ENT I="01">200-701</ENT> <ENT>PARASEDGE Multi for Cats (Imidacloprid and moxidectin)</ENT> <ENT>Do</ENT> <ENT>Do</ENT> <ENT>524.1146</ENT> </ROW> </GPOTABLE> <HD SOURCE="HD1">IV. Change of Sponsor Address</HD> Accord Healthcare, Inc. 1009 Slater Rd., Suite 210-B, Durham, NC 27703 (drug labeler code 016729 in 21 CFR 510.600(c)) has informed FDA ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 31k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━