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

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Parts 510, 520, 522, 524, 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</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 July, August, and September 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 December 2, 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 July, August, and September 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 and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval under the Freedom of Information Act. 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="xs70,8,r50,r50,r50,8"> <TTITLE>Table 1—Original and Supplemental NADAs and ANADAs Approved During July, August, and September 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>Bimeda Animal Health Ltd. (061133)</ENT> <ENT>MOXISOLV Injection (moxidectin)</ENT> <ENT>Original approval as a generic copy of NADA 141-220</ENT> <ENT>522.1450</ENT> </ROW> <ROW> <ENT I="01">July 8, 2024</ENT> <ENT>200-771</ENT> <ENT>Norbrook Laboratories, Ltd. (055529)</ENT> <ENT>FELANORM (methimazole) Oral Solution</ENT> <ENT>Original approval as a generic copy of NADA 141-292</ENT> <ENT>520.1372</ENT> </ROW> <ROW> <ENT I="01">August 15, 2024</ENT> <ENT>200-770</ENT> <ENT>Pharmgate Inc. (069254)</ENT> <ENT>DERACIN (chlortetracycline) and MGA (melengestrol acetate) Type C medicated feeds</ENT> <ENT>Original approval as a generic copy of NADA 141-530</ENT> <ENT>558.128</ENT> </ROW> <ROW> <ENT I="01">August 26, 2024</ENT> <ENT>200-783</ENT> <ENT>Huvepharma EOOD (016592)</ENT> <ENT>COXIDIN 90 (monensin) Type C medicated feeds</ENT> <ENT>Original approval as a generic copy of NADA 038-878 and NADA 130-736</ENT> <ENT>558.355</ENT> </ROW> <ROW> <ENT I="01">September 5, 2024</ENT> <ENT>200-795</ENT> <ENT>Felix Pharmaceuticals Pvt. Ltd. (086101)</ENT> <ENT>CARPROFEN Soft Chewable Tablets (carprofen)</ENT> <ENT>Original approval as a generic copy of NADA 141-111</ENT> <ENT>520.304</ENT> </ROW> <ROW> <ENT I="01">September 5, 2024</ENT> <ENT>200-773</ENT> <ENT>Cronus Pharma Specialties India Private Ltd. (069043)</ENT> <ENT>TULAJECT 100 (tulathromycin injection) Injectable Solution</ENT> <ENT>Original approval as a generic copy of NADA 141-224</ENT> <ENT>522.2630</ENT> </ROW> <ROW> <ENT I="01">September 10, 2024</ENT> <ENT>200-774</ENT> <ENT>Do</ENT> <ENT>TULAJECT 25 (tulathromycin injection) Injectable Solution</ENT> <ENT>Original approval as a generic copy of NADA 141-349</ENT> <ENT>Do.</ENT> </ROW> <ROW> <ENT I="01">September 19, 2024</ENT> <ENT>141-585</ENT> <ENT>Elanco US Inc. (058198)</ENT> <ENT>ZENRELIA (ilunocitinib tablet)</ENT> <ENT>Original approval for control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs</ENT> <ENT>520.1136</ENT> </ROW> <ROW> <ENT I="01">September 23, 2024</ENT> <ENT>200-776</ENT> <ENT>Pharmgate Inc. (069254</ENT> <ENT>DERACIN (chlortetracycline), BOVATEC (lasalocid), and MGA (melengestrol acetate) Type C medicated feeds</ENT> <ENT>Original approval as a generic copy of NADA 141-531</ENT> <ENT>558.128</ENT> </ROW> <TNOTE> <SU>1</SU>  See 21 CFR 510.600(c) for sponsor addresses. </TNOTE> </GPOTABLE> <HD SOURCE="HD1">II. Withdrawals of Approval</HD> Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767-1861 (drug labeler code 054925) requested that FDA withdraw approval of the two 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,r100,9"> <TTITLE>Table 2—Applications for Which Approval Was Voluntarily Withdrawn During July, August, and September 2024</TTITLE> <CHED H="1"> Date of withdrawal of approval </CHED> <CHED H="1">File No.</CHED> <CHED H="1">Product name</CHED> <ENT>Nitrofurazone Anesthetic Dressing (nitrofurazone and butacaine sulfate)</ENT> <ENT>524.1580c</ENT> </ROW> <ROW> <ENT I="01">Do</ENT> <ENT>140-881</ENT> <ENT>Nitrofurazone Soluble Dressing (nitrofurazone)</ENT> <ENT>524.1580a</ENT> </ROW> </GPOTABLE> <HD SOURCE="HD1">III. Change of Sponsor</HD> Cephazone Pharma, LLC, 250 East Bonita Ave., Pomona, CA 91767 has informed FDA that it has transferred ownership of, and all rights and interest in, ANADA 200-420 for Ceftiofur Sodium Sterile Powder to Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211. As provided in the regulatory text, the animal drug regulations 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(c) is amended to remove Cephazone Pharma, LLC and Provetica LLC from the lists of sponsors of approved applications as these firms are no longer the sponsor of an approved application. • 21 CFR 520.522 is amended to reflect a 2023 change of sponsorship for cyclosporine oral solution. • 21 CFR 520.2090 is amended to revise the description of a tablet containing sarolaner, moxidectin, and pyrantel. • 21 CFR 522.2470 is being amended to reflect previous approval of additional indications for use of tiletamine and zolazepam. <HD SOURCE="HD1">V. 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, 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 510</CFR> Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. <CFR>21 CFR Parts 520, 522, and 524</CFR> Animal drugs. <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 510, 520, 522, 524, and 558 are amended as follows: <HD SOURCE="HED">PART 510—NEW ANIMAL DRUGS</HD> <REGTEXT TITLE="21" PART="510"> 1. The authority citation for part 510 continues to read as follows: <HD SOURCE="HED">Authority:</HD> 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. </REGTEXT> <SECTION> <SECTNO>§ 510.600</SECTNO> <SUBJECT>[Amended]</SUBJECT> </SECTION> <REGTEXT TITLE="21" PART="510"> 2. In § 510.600, in the table in paragraph (c)(1), remove the entries for “Cephazone Pharma, LLC” and “Provetica LLC”; and in the table in paragraph (c)(2), remove the entries for “068330” and “086097”. </REGTEXT> <HD SOURCE="HED">PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS</HD> <REGTEXT TITLE="21" PART="520"> 3. The authority citation for part 520 continues to read as follows: <HD SOURCE="HED">Authority:</HD> 21 U.S.C. 360b. </REGTEXT> <SECTION> <SECTNO>§ 520.304</SECTNO> <SUBJECT>[Amended]</SUBJECT> </SECTION> <REGTEXT TITLE="21" PART="520"> 4. In § 520.304, in paragraph (b)(2), add in numerical order the text “086101”. </REGTEXT> <SECTION> <SECTNO>§ 520.522</SECTNO> <SUBJECT>[Amended]</SUBJECT> </SECTION> <REGTEXT TITLE="21" PART="520"> 5. In § 520.522 in paragraph (b)(4), remove the text “086097” and add in its place the text “013744”. </REGTEXT> <REGTEXT TITLE="21" PART="520"> 6. Add § 520.1136 to read as follows: <SECTION> <SECTNO>§ 520.1136</SECTNO> <SUBJECT>Ilunocitinib.</SUBJECT> (a) <E T="03">Specifications.</E> Each tablet contains 4.8, 6.4, 8.5, and 15 milligrams (mg) ilunocitinib. (b) <E T="03">Sponsor.</E> See No. 058198 in § 510.600(c) of this chapter. (c) <E T="03">Conditions of use</E> —(1) <E T="03">Amount.</E> Administer orally 0.27 to 0.36 mg ilunocitinib/lb (0.6 to 0.8 mg ilunocitinib/kg) body weight, once daily, with or without food. (2) <E T="03">Indications for use.</E> For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (3) <E T="03">Limitation ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 41k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━