Document ID: FDA-2010-N-0002-0027
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs: Change of Sponsor; Propofol
Posted Date: 2010-04-19T04:00Z

[Federal Register: April 19, 2010 (Volume 75, Number 74)]
[Rules and Regulations]               
[Page 20268-20269]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19ap10-5]                         

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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; Change 
of Sponsor; Propofol

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 a change of sponsor for a new animal drug 
application (NADA) from Intervet, Inc., to Teva Animal Health, Inc.

DATES:  This rule is effective April 19, 2010.

FOR FURTHER INFORMATION CONTACT:  David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail: 
david.newkirk@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Intervet, Inc., 56 Livingston Ave., 
Roseland, NJ 07068, has informed FDA that it has transferred ownership 
of, and all rights and interest in, approved NADA 141-070 for RAPINOVET 
(propofol), an

[[Page 20269]]

injectable anesthetic, to Teva Animal Health, Inc., 3915 South 48th 
Street Ter., St. Joseph, MO 64503. Accordingly, the agency is amending 
the regulations in 21 CFR 522.2005 to reflect the transfer of ownership 
and a current format.
    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.
    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

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

0
2. Revise Sec.  522.2005 to read as follows:

Sec.  522.2005   Propofol.

    (a) Specifications. Each milliliter of emulsion contains 10 
milligrams (mg) propofol.
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter.
    (1) No. 059130 for use as in paragraph (c) of this section.
    (2) No. 000074 for use as in paragraphs (c)(1)(i), (c)(2), and 
(c)(3) of this section.
    (c) Conditions of use in dogs and cats--(1) Amount. The drug is 
administered by intravenous injection as follows:
    (i) Dogs. For induction of general anesthesia without the use of 
preanesthetics the dosage is 5.5 to 7.0 mg per kilogram (mg/kg) (2.5 to 
3.2 mg/pound (lb)); for the maintenance of general anesthesia without 
the use of preanesthetics the dosage is 1.1 to 3.3 mg/kg (0.5 to 1.5 
mg/lb). The use of preanesthetic medication reduces propofol dose 
requirements.
    (ii) Cats. For induction of general anesthesia without the use of 
preanesthetics the dosage is 8.0 to 13.2 mg/kg (3.6 to 6.0 mg/lb). For 
the maintenance of general anesthesia without the use of preanesthetics 
the dosage is 1.1 to 4.4 mg/kg (0.5 to 2.0 mg/lb). The use of 
preanesthetic medication reduces propofol dose requirements.
    (2) Indications for use. As a single injection to provide general 
anesthesia for short procedures; for induction and maintenance of 
general anesthesia using incremental doses to effect; for induction of 
general anesthesia where maintenance is provided by inhalant 
anesthetics.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: April 13, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 2010-8945 Filed 4-16-10; 8:45 am]
BILLING CODE 4160-01-S