[Federal Register Volume 59, Number 156 (Monday, August 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-19926]


[[Page Unknown]]

[Federal Register: August 15, 1994]


-----------------------------------------------------------------------


DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 522

 

Implantation or Injectable Dosage Form New Animal Drugs; 
Butorphanol Tartrate Injection

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a new animal drug application 
(NADA) filed by Fort Dodge Laboratories. The NADA provides for the use 
of butorphanol tartrate injection in cats for the relief of pain caused 
by major or minor trauma, or pain associated with surgical procedures.

EFFECTIVE DATE:  August 15, 1994.

FOR FURTHER INFORMATION CONTACT: Marcia K. Larkins, Center for 
Veterinary Medicine (HFV-112), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-0614.

SUPPLEMENTARY INFORMATION: Fort Dodge Laboratories, Fort Dodge, IA 
50501, currently holds approval for NADA 102-990 which provides for use 
of butorphanol tartrate injection for the treatment of dogs for relief 
of chronic nonproductive cough originating from inflammatory conditions 
of the upper respiratory tract and for NADA 135-780 which provides for 
use of the drug for the treatment of horses and yearlings for relief of 
pain associated with colic, and for postpartum pain. The firm has filed 
NADA 141-047 which provides for use of a new concentration (2 
milligrams per milliliter) of the drug in cats for the relief of pain 
caused by major or minor trauma, or pain associated with surgical 
procedures. The NADA is approved as of July 5, 1994, and the 
regulations are amended in 21 CFR 522.246 to reflect the approval. The 
basis for approval is discussed in the freedom of information summary.
    In accordance with the freedom of information provisions of part 20 
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (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 Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m., 
Monday through Friday.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval for nonfood 
producing animals qualifies for 3 years of marketing exclusivity 
beginning July 5, 1994, because the application contains reports of new 
clinical or field investigations (other than bioequivalence studies) 
essential to the approval of the application and conducted or sponsored 
by the applicant.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

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

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

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

    2. Section 522.246 is amended in paragraph (a) by adding ``, 2'' 
after ``0.5'' and before the word ``or'', and by adding new paragraph 
(c)(3) to read as follows:

Sec. 522.246  Butorphanol tartrate injection.

* * * * *

    (c) * * *

    (3) Cats--(i) Amount. 0.2 milligram of butorphanol base activity 
per pound of body weight (0.4 milligram/kilogram), using 2 milligrams 
per milliliter solution.

    (ii) Indications for use. For the relief of pain in cats caused by 
major or minor trauma, or pain associated with surgical procedures.

    (iii) Limitations. For subcutaneous injection in cats only. Dose 
may be repeated up to 4 times per day. Do not treat for more than 2 
days. Safety for use in pregnant female cats, breeding male cats or 
kittens less than 4 months of age has not been determined. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

    Dated: August 8, 1994.

Richard H. Teske,

Deputy Director, Premarket Review, Center for Veterinary Medicine.

[FR Doc. 94-19926 Filed 8-12-94; 8:45 am]

BILLING CODE 4160-01-F