The eRulemaking Program
05/08/2025 | Press release | Distributed by Public on 05/09/2025 06:31
New Animal Drugs: Approval of New Animal Drug Applications, Withdrawal of Approval of New Animal Drug Application, Change of Sponsor; Technical Amendments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 516, 520, 522, and 524
[Docket No. FDA-2025-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule; technical amendments.
SUMMARY:
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 January, February, and March 2025. The animal drug regulations are also being amended to improve their accuracy and readability.
DATES:
This rule is effective May 9, 2025.
FOR FURTHER INFORMATION CONTACT:
Barbara Leotta, DVM, Deputy Office Director, Office of New Animal Product Evaluation Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0605, Barbara.Leotta@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Approval of New Animal Drug Applications
FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during January, February, and March 2025, 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: https://animaldrugsatfda.fda.gov/adafda/views/#/search.
Table 1-Original and Supplemental NADAs and ANADAs Approved During January, February, and March 2025 Requiring Evidence of Safety and/or Effectiveness
| Date of approval | File No. | Sponsor (drug labeler code 1 ) | Product name | Effect of the action | 21 CFR section |
| January 13, 2025 | 200-626 | Bimeda Animal Health Ltd. (061133) | EPRIMECTIN Pour-On (eprinomectin) | Original approval as a generic copy of NADA 141-079 | 524.814 |
| February 25, 2025 | 200-742 | Hikma Pharmaceuticals USA, Inc. (086194 | Tulathromycin Injection (tulathromycin injection) Injectable Solution | Original approval as a generic copy of NADA 141-244 | 522.2630 |
| 1 See 21 CFR 510.600(c) for sponsor addresses. | |||||
II. Withdrawal of Approval of New Animal Drug Applications
Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA 30096 (drug labeler code 000010) requested that FDA withdraw approval of ANADA 200-088 for SEDAZINE (xylazine hydrochloride) Injectable Solution because the product is no longer manufactured or marketed. Accordingly, approval of ANADA 200-088 was withdrawn effective December 10, 2023. The animal drug regulations are being amended to reflect this action.
III. Changes of Sponsor
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 2 are amended to reflect these actions.
Table 2-Applications for Which Ownership Was Transferred to Another Sponsor During January, February, and March 2025
| File No. | Product name | Transferring sponsor(drug labeler code) | New sponsor (drug labeler code) | 21 CFR section |
| 200-379 | VETPROFEN (carprofen) Caplets | Belcher Pharmaceuticals, Inc. (051233) | Ajenat Pharmaceuticals, LLC (082983) | 520.304 |
| 200-578 | Carprofen Flavored Tablets (carprofen) | Do | Do | 520.304 |
IV. Technical Amendments
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 entries for Belcher Pharmaceuticals, LLC, as the firm is no longer the sponsor of approved applications, and to add entries for Ajenat Pharmaceuticals, LLC and Hikma Pharmaceuticals USA, Inc.
- 21 CFR 522.772 is amended to present an accurate list of bovine parasites.
- 21 CFR 522.2005 is amended to introduce sponsor drug labeler codes for approved propofol injectable solution.
- 21 CFR 522.2630(c) is amended to present the sequence of drug labeler codes for tulathromycin injectable solutions.
V. Legal Authority
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.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
21 CFR Part 516
Administrative practice and procedure, Animal drugs, Confidential business information, Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, and 524
Animal drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 510, 516, 520, 522, and 524 are amended as follows:
PART 510-NEW ANIMAL DRUGS
Regulatory Text
1. The authority citation for part 510 continues to read as follows:
Authority:
21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
2. In § 510.600:
a. In the table in paragraph (c)(1):
i. Remove the entry for "Belcher Pharmaceuticals, LLC";
ii. Add an entry for "Ajenat Pharmaceuticals, LLC"; and
iii. Add an entry for "Hikma Pharmaceuticals USA, Inc."; and
b. In the table in paragraph (c)(2):
i Remove the entry for "062250"; and
ii Add entries for "082983" and "086194".
The additions read as follows:
§ 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.
* * * * *
(c) * * *
(1) * * *
| Firm name and address | Drug labeler code |
| * * * * * * * | |
| Ajenat Pharmaceuticals, LLC, 6911 Bryan Dairy Rd., Suite 210, Largo, FL 33777 | 082983 |
| * * * * * * * | |
| Hikma Pharmaceuticals USA, Inc., 2 Esterbrook Ln., Cherry Hill, NJ 08003 | 086194 |
| * * * * * * * |
(2) * * *
| Drug labeler code | Firm name and address |
| * * * * * * * | |
| 082983 | Ajenat Pharmaceuticals, LLC, 6911 Bryan Dairy Rd., Suite 210, Largo, FL 33777 |
| * * * * * * * | |
| 086194 | Hikma Pharmaceuticals USA, Inc., 2 Esterbrook Ln., Cherry Hill, NJ 08003 |
| * * * * * * * |
PART 516-NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
Regulatory Text
3. The authority citation for part 516 continues to read as follows:
Authority:
21 U.S.C. 360ccc-1, 360ccc-2, 371.
4. Add § 516.2106 to subpart E to read as follows:
§ 516.2106 Sirolimus.
(a) Specifications. Each sustained-release tablet contains 0.4, 1.2, or 2.4 milligrams (mg) sirolimus.
(b) Sponsor. See No. 086169 in § 510.600(c) of this chapter.
(c) Conditions of use in cats -(1) Amount. Administer orally once weekly at a dose of 0.3 mg/kilogram of bodyweight.
(2) Indications for use. For the management of ventricular hypertrophy in cats with subclinical hypertrophic cardiomyopathy (HCM).
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling.
PART 520-ORAL DOSAGE FORM NEW ANIMAL DRUGS
Regulatory Text
5. The authority citation for part 520 continues to read as follows:
Authority:
21 U.S.C. 360b.
§ 520.304
[Amended]
Regulatory Text
6. In § 520.304, in paragraph (b)(1), remove the text "062250" and in its place add the text "082983".
PART 522-IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
Regulatory Text
7. The authority citation for part 522 continues to read as follows:
Authority:
21 U.S.C. 360b.
§ 522.772
[Amended]
Regulatory Text
8. In § 522.772, in paragraph (d)(1)(ii), remove the text " Oncophora, Cooperia pectinata (adults only)" and in its place add the text " Cooperia oncophora, C. pectinata (adults only)"
9. In § 522.2005, revise paragraph (b) introductory text to read as follows:
§ 522.2005 Propofol.
* * * * *
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter.
* * * * *
§ 522.2662
[Amended]
Regulatory Text
10. In § 522.2662, in paragraph (b)(2), remove the text "Nos. 000010 and 061133" and in its place add the text "No. 061133".
PART 524-OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
Regulatory Text
11. The authority citation for part 524 continues to read as follows:
Authority:
21 U.S.C. 360b.
§ 524.814
[Amended]
Regulatory Text
12. In § 524.814, in paragraph (b), remove the text "and 055529" and in its place add the text "055529, and 061133".
Dated: May 5, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-08137 Filed 5-8-25; 8:45 am]
BILLING CODE 4164-01-P
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