Document ID: FDA-2010-N-0002-0035
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs: Butorphanol
Posted Date: 2010-04-29T04:00Z

[Federal Register: April 29, 2010 (Volume 75, Number 82)]
[Rules and Regulations]               
[Page 22524]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29ap10-10]                         

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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: 
john.harshman@fda.hhs.gov.

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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