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 January, February, and March 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 May 15, 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 and ANADAs during January, February, and March 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 <E T="03"> Animal Drugs @FDA: https://animaldrugsatfda.fda.gov/adafda/views/#/search.</E> <GPOTABLE COLS="6" OPTS="L2,nj,p7,7/8,i1" CDEF="xs72,9,r50,r50,r50,9"> <TTITLE>Table 1—Original and Supplemental NADAs and ANADAs Approved During January, February, and March 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>Aurora Pharmaceutical, Inc., 1196 Highway 3 South, Northfield, MN 55057-3009 (051072)</ENT> <ENT>EQUICOXIB (firocoxib) Oral Solution</ENT> <ENT>Original approval as a generic copy of NADA 141-253</ENT> <ENT>520.929</ENT> </ROW> <ROW> <ENT I="01">January 12, 2024</ENT> <ENT>200-768</ENT> <ENT>Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria (016592)</ENT> <ENT>RAVANTAGE 9 and RAVANTAGE 45 (ractopamine hydrochloride) Type A Medicated Articles</ENT> <ENT>Original approval as a generic copy of NADA 140-863</ENT> <ENT>558.500</ENT> </ROW> <ROW> <ENT I="01">January 12, 2024</ENT> <ENT>200-767</ENT> <ENT>Felix Pharmaceuticals Pvt. Ltd., 25-28 North Wall Quay, Dublin 1, Ireland (086101)</ENT> <ENT>Carprofen Tablets</ENT> <ENT>Original approval as a generic copy of NADA 141-053</ENT> <ENT>520.304</ENT> </ROW> <ROW> <ENT I="01">January 30, 2024</ENT> <ENT>200-769</ENT> <ENT>ZyVet Animal Health, Inc., 73 Route 31N, Pennington, NJ 08534 (086117)</ENT> <ENT>SELAMECTIN Topical Solution</ENT> <ENT>Original approval as a generic copy of NADA 141-152</ENT> <ENT>524.2098</ENT> </ROW> <ROW> <ENT I="01">February 13, 2024</ENT> <ENT>141-575</ENT> <ENT>Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA 30096 (000010)</ENT> <ENT>VETMEDIN (pimobendan oral solution) Solution</ENT> <ENT>Original approval for management of the signs of mild, moderate, or severe congestive heart failure in dogs</ENT> <ENT>520.1782</ENT> </ROW> <ROW> <ENT I="01">February 22, 2024</ENT> <ENT>200-749</ENT> <ENT>Ceva Sante Animale, 10 Avenue de la Ballastière, 33500 Libourne, France (013744)</ENT> <ENT>KESIUM (amoxicillin and clavulanate potassium tablets) Chewable Tablets</ENT> <ENT>Original approval as a generic copy of NADA 055-099</ENT> <ENT>520.88g</ENT> </ROW> <ROW> <ENT I="01">March 1, 2024</ENT> <ENT>200-772</ENT> <ENT>Parnell Technologies Pty. Ltd., unit 4, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia (068504)</ENT> <ENT>CONTRASED (atipamezole hydrochloride) Injectable Solution</ENT> <ENT>Original approval as a generic copy of NADA 141-033</ENT> <ENT>522.147</ENT> </ROW> <ROW> <ENT I="01">March 15, 2024</ENT> <ENT>141-579</ENT> <ENT>Dechra Ltd. Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire, BD23 2RW, United Kingdom (043264)</ENT> <ENT>DUOTIC (terbinafine and betamethasone acetate otic gel) Otic Gel</ENT> <ENT> Original approval for treatment of otitis externa in dogs, associated with susceptible strains of yeast ( <E T="03">Malassezia pachydermatis</E> ) </ENT> <ENT>524.2338</ENT> </ROW> </GPOTABLE> <HD SOURCE="HD1">II. Withdrawals of Approval</HD> Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA 30096 (drug labeler code 000010) requested that FDA withdraw approval of the five 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,i1" CDEF="xs72,9,r50,9"> <TTITLE>Table 2—Applications for Which Approval Was Voluntarily Withdrawn During January, February, and March 2024</TTITLE> <CHED H="1">Date of withdrawal of approval</CHED> <CHED H="1">File No.</CHED> <CHED H="1">Product name</CHED> <ENT>ENACARD (enalapril maleate) Tablets</ENT> <ENT>520.804</ENT> </ROW> <ROW> <ENT I="01">Do</ENT> <ENT>141-096</ENT> <ENT>DICURAL (difloxacin hydrochloride) Tablets</ENT> <ENT>520.645</ENT> </ROW> <ROW> <ENT I="01">Do</ENT> <ENT>141-108</ENT> <ENT>ETOGESIC (etodolac) Tablets</ENT> <ENT>520.870</ENT> </ROW> <ROW> <ENT I="01">Do</ENT> <ENT>141-274</ENT> <ENT>ETOGESIC (etodolac) Injectable Solution</ENT> <ENT>522.870</ENT> </ROW> <ROW> <ENT I="01">Do</ENT> <ENT>141-421</ENT> <ENT>DUOCARE (ivermectin and praziquantel) Paste</ENT> <ENT>520.1198</ENT> </ROW> </GPOTABLE> <HD SOURCE="HD1">III. Changes 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="xs72,r50,r50,r50,9"> <TTITLE>Table 3—Applications for Which Ownership Was Transferred to Another Sponsor During January, February, and March 2024</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>Piramal Critical Care, Inc., 3850 Schelden Circle, Bethlehem, PA 18017 (066794)</ENT> <ENT>Piramal Pharma Ltd., Ground floor, Piramal Ananta, Agastya Corporate Park, Mumbai, Maharashtra—400070, India (065085)</ENT> <ENT>529.1186</ENT> </ROW> <ROW> <ENT I="01">200-237</ENT> <ENT>Isoflurane, USP</ENT> <ENT>Do</ENT> <ENT>Do</ENT> <ENT>Do.</ENT> </ROW> <ROW> <ENT I="01">200-338</ENT> <ENT>TRI-HEART (ivermectin and pyrantel pamoate) Tablets</ENT> <ENT>Heska Corp., 3760 Rocky Mountain Ave., Loveland, CO 80538-7084 (063604)</ENT> <ENT>Diamond Animal Health, Inc., 2538 SE 43rd St., Des Moines, IA 50327 (053701)</ENT> <ENT>510.600 520.1196</ENT> </ROW> <ROW> <ENT I="01">200-438</ENT> <ENT>PETREM (sevoflurane)</ENT> <ENT>Piramal Critical Care, Inc., 3850 Schelden Circle, Bethlehem, PA 18017 (066794)</ENT> <ENT>Piramal Pharma Ltd., Ground floor, Piramal Ananta, Agastya Corporate Park, Mumbai, Maharashtra—400070, India (065085)</ENT> <ENT>529.2110</ENT> </ROW> </GPOTABLE> <HD SOURCE="HD1">IV. Change of Sponsor Address</HD> ECO LLC, 344 Nassau St., Princeton, NJ 08540 (drug labeler code 066916 in 21 CFR 510.600(c)) has informed FDA that it has changed its address to 11224 Aurora Ave., Urbandale, IA 50322. The entries in § 510.600(c) are amended to reflect this action. <HD SOURCE="HD1">V. 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 remove entries for Heska Corp. and Piramal Critical Care, Inc. from the lists of sponsors of approved applications, to revise the entries for Cronus Pharma Specialities India Private Ltd. and ECO LLC; and to add entries for Diamond Animal Health, Inc. • 21 CFR 522.840 is amended to reflect revisions to approved labeling for cattle implants containing estradiol. • 21 CFR 522.1940 is amended to reflect the current format for regulations and revisions to approved labeling for cattle implants containing progesterone and estradiol benzoate. • 21 CFR 522.2343 is amended to reflect revisions to approved labeling for cattle implants containing testosterone propionate and estradiol benzoate. • 21 CFR 522.2477 is amended to reflect revisions to approved labeling for cattle implants containing trenbolone acetate and estradiol. • 21 CFR 524.1193 is amended to reflect periods of persistent activity for an approved generic ivermectin topical solution used in cattle. • 21 CFR 558.485 is amended to reflect an inclusion rate for pyrantel tartrate in medicated horse feeds. <HD SOURCE="HD1">VI. 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 pursuant to the FD&C Act, t ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 49k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━