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[Federal Register: May 18, 2007 (Volume 72, Number 96)]
[Rules and Regulations]               
[Page 27956-27957]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18my07-6]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

 
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 abbreviated new animal drug 
application (ANADA) filed by IVX Animal Health, Inc. The ANADA provides 
for veterinary prescription use of butorphanol tartrate injectable 
solution in cats for the relief of pain.

DATES: This rule is effective May 18, 2007.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: IVX Animal Health, Inc., 3915 South 48th 
Street Ter., St. Joseph, MO 64503, filed ANADA 200-408 that provides 
for veterinary prescription use of Butorphanol Tartrate Injection (2mg/
mL) in cats for the relief of pain. IVX Animal Health, Inc.'s 
Butorphanol Tartrate Injection (2mg/mL) is approved as a generic copy 
of Fort Dodge Animal Health, a Div. of Wyeth's TORBUGESIC-SA 
(butorphanol tartrate, USP), approved under NADA 141-047. The ANADA is 
approved as of April 20, 2007, and the regulations are amended in 21 
CFR 522.246 to reflect the approval and a current format.
    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(a)(1) 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.

[[Page 27957]]

    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.

0
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.  522.246 to read as follows:

Sec.  522.246  Butorphanol.

    (a) Specifications. Each milliliter of solution contains 
butorphanol (as butorphanol tartrate) in the following amounts:
    (1) 0.5 milligrams (mg);
    (2) 2 mg; or
    (3) 10 mg
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter as 
follows:
    (1) No. 000856 for use of the product described in paragraph (a)(1) 
as in paragraph (d)(1) of this section; for use of the product 
described in paragraph (a)(2) as in paragraph (d)(2) of this section; 
and for use of the product described in paragraph (a)(3) as in 
paragraph (d)(3) of this section.
    (2) No. 059130 for use of the product described in paragraph (a)(2) 
as in paragraph (d)(2) of this section.
    (3) Nos. 057926 and 059130 for use of the product described in 
paragraph (a)(3) as in paragraph (d)(3) of this section.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) Conditions of use--(1) Dogs--(i) Amount. Administer 0.025 mg 
per pound of body weight by subcutaneous injection at intervals of 6 to 
12 hours, as required. If necessary, increase dose to a maximum of 0.05 
mg per pound of body weight. Treatment should not normally be required 
for longer than 7 days.
    (ii) Indications for use. For the relief of chronic nonproductive 
cough associated with tracheo-bronchitis, tracheitis, tonsillitis, 
laryngitis, and pharyngitis associated with inflammatory conditions of 
the upper respiratory tract.
    (2) Cats--(i) Amount. Administer 0.2 mg per pound of body weight by 
subcutaneous injection. Dose may be repeated up to 4 times per day. Do 
not treat for more than 2 days.
    (ii) Indications for use. For the relief of pain in cats caused by 
major or minor trauma, or pain associated with surgical procedures.
    (3) Horses--(i) Amount. Administer 0.05 mg per pound of body weight 
by intravenous injection. Dose may be repeated within 3 to 4 hours. 
Treatment should not exceed 48 hours.
    (ii) Indications for use. For the relief of pain associated with 
colic and postpartum pain in adult horses and yearlings.
    (iii) Limitations. Do not use in horses intended for human 
consumption.

    Dated: May 3, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-9557 Filed 5-17-07; 8:45 am]

BILLING CODE 4160-01-S

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