Rule2025-08137
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor
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Published
May 9, 2025
Effective
May 9, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 90 Issue 89 (Friday, May 9, 2025)</title>
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[Federal Register Volume 90, Number 89 (Friday, May 9, 2025)]
[Rules and Regulations]
[Pages 19623-19625]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-08137]
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Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
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Federal Register / Vol. 90, No. 89 / Friday, May 9, 2025 / Rules and
Regulations
[[Page 19623]]
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, <a href="/cdn-cgi/l/email-protection#581a392a3a392a3976143d372c2c39183e3c397630302b763f372e"><span class="__cf_email__" data-cfemail="adefccdfcfccdfcc83e1c8c2d9d9ccedcbc9cc83c5c5de83cac2db">[email protected]</span></a>.
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: <a href="https://animaldrugsatfda.fda.gov/adafda/views/#/search">https://animaldrugsatfda.fda.gov/adafda/views/#/search</a>.
Table 1--Original and Supplemental NADAs and ANADAs Approved During January, February, and March 2025 Requiring
Evidence of Safety and/or Effectiveness
----------------------------------------------------------------------------------------------------------------
Sponsor (drug Effect of the 21 CFR
Date of approval File No. labeler code \1\) Product name action section
----------------------------------------------------------------------------------------------------------------
January 13, 2025............ 200-626 Bimeda Animal EPRIMECTIN Pour-On Original approval 524.814
Health Ltd. (eprinomectin). as a generic copy
(061133). of NADA 141-079.
February 25, 2025........... 200-742 Hikma Tulathromycin Original approval 522.2630
Pharmaceuticals Injection as a generic copy
USA, Inc. (086194. (tulathromycin of NADA
injection) 141[dash]244.
Injectable
Solution.
----------------------------------------------------------------------------------------------------------------
\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
----------------------------------------------------------------------------------------------------------------
Transferring sponsor New sponsor (drug 21 CFR
File No. Product name (drug labeler code) labeler code) section
----------------------------------------------------------------------------------------------------------------
200-379............... VETPROFEN (carprofen) Belcher Pharmaceuticals, Ajenat Pharmaceuticals, 520.304
Caplets. Inc. (051233). LLC (082983).
200-578............... Carprofen Flavored Do...................... Do...................... 520.304
Tablets (carprofen).
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[[Page 19624]]
IV. Technical Amendments
FDA is making the following amendments to improve the accuracy and
readability of the animal drug regulations.
<bullet> 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.
<bullet> 21 CFR 522.772 is amended to present an accurate list of
bovine parasites.
<bullet> 21 CFR 522.2005 is amended to introduce sponsor drug
labeler codes for approved propofol injectable solution.
<bullet> 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
0
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.
0
2. In Sec. 510.600:
0
a. In the table in paragraph (c)(1):
0
i. Remove the entry for ``Belcher Pharmaceuticals, LLC'';
0
ii. Add an entry for ``Ajenat Pharmaceuticals, LLC''; and
0
iii. Add an entry for ``Hikma Pharmaceuticals USA, Inc.''; and
0
b. In the table in paragraph (c)(2):
0
i Remove the entry for ``062250''; and
0
ii Add entries for ``082983'' and ``086194''.
The additions read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * * * *
Ajenat Pharmaceuticals, LLC, 6911 Bryan Dairy Rd., Suite 082983
210, Largo, FL 33777...................................
* * * * * * *
Hikma Pharmaceuticals USA, Inc., 2 Esterbrook Ln., 086194
Cherry Hill, NJ 08003..................................
* * * * * * *
------------------------------------------------------------------------
(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
0
3. The authority citation for part 516 continues to read as follows:
Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.
0
4. Add Sec. 516.2106 to subpart E to read as follows:
Sec. 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 Sec. 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.
[[Page 19625]]
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
5. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 520.304 [Amended]
0
6. In Sec. 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
0
7. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 522.772 [Amended]
0
8. In Sec. 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)''
0
9. In Sec. 522.2005, revise paragraph (b) introductory text to read as
follows:
Sec. 522.2005 Propofol.
* * * * *
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter.
* * * * *
Sec. 522.2662 [Amended]
0
10. In Sec. 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
0
11. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 524.814 [Amended]
0
12. In Sec. 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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