[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]
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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.
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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