[Federal Register Volume 75, Number 82 (Thursday, April 29, 2010)]
[Rules and Regulations]
[Page 22524]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-9871]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA-2010-N-0002]
Implantation or Injectable Dosage Form New Animal Drugs;
Butorphanol
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of an original abbreviated new
animal drug application (ANADA) filed by Modern Veterinary
Therapeutics, LLC. The ANADA provides for use of an injectable solution
of butorphanol tartrate in cats for the relief of pain.
DATES: This rule is effective April 29, 2010.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-170), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: Modern Veterinary Therapeutics, LLC, 1550
Madruga Ave., suite 329, Coral Gables, FL 33146, filed ANADA 200-446
for the use of BUTORPHINE (butorphanol tartrate, USP) Veterinary
Injection in cats for the relief of pain. Modern Veterinary
Therapeutics' BUTORPHINE Veterinary Injection is approved as a generic
copy of TORBUGESIC-SA (butorphanol tartrate, USP) Veterinary Injection,
approved under NADA 141-047 held by Fort Dodge Animal Health, Division
of Wyeth, a wholly owned subsidiary of Pfizer, Inc. The ANADA is
approved as of March 26, 2010, and the regulations in 21 CFR 522.246
are amended to reflect the approval.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application may be seen in the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
FDA has determined under 21 CFR 25.33 that this action is of a type
that does not individually or cumulatively have a significant effect on
the human environment. Therefore, neither an environmental assessment
nor an environmental impact statement is required.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects in 21 CFR Part 522
Animal drugs.
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Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
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1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.246 [Amended]
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2. In paragraph (b)(2) of Sec. 522.246, remove ``No. 059130'' and in
its place add ``Nos. 015914 and 059130''.
Dated: April 23, 2010.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2010-9871 Filed 4-28-10; 8:45 am]
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