[Federal Register Volume 59, Number 210 (Tuesday, November 1, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-27069]
[[Page Unknown]]
[Federal Register: November 1, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Animal Drugs, Feeds, and Related Products; Ceftiofur
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 supplemental new animal drug
application (NADA) filed by The Upjohn Co. The supplemental NADA
provides for use of ceftiofur sterile powder as an aqueous injectable
for dogs for treatment of canine urinary tract infections associated
with Escherichia coli and Proteus mirabilis.
EFFECTIVE DATE: November 1, 1994.
FOR FURTHER INFORMATION CONTACT: Charles W. Francis, Center for
Veterinary Medicine (HFV-114), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1617.
SUPPLEMENTARY INFORMATION: The Upjohn Co. Kalamazoo, MI 49001, filed
supplemental NADA 140-338, which provides for use of Naxcel
Sterile Powder (ceftiofur sodium) reconstituted as a 50 milligrams per
milliliter (mg/mL) injectable solution for treating dogs for urinary
tract infections associated with Escherichia coli and Proteus
mirabilis. The product is currently approved for use in cattle, swine,
horses, and day-old chicks. The supplemental NADA is approved as of
October 4, 1994, and the regulations in 21 CFR 522.313 are amended by
adding new paragraph (d)(5) 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)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval qualifies
for 3 years of marketing exclusivity beginning October 4, 1994, because
the supplemental application contains reports of new clinical or field
investigations, other than bioequivalence or residue studies, essential
to the approval 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 522.313 is amended by adding new paragraph (d)(5) to
read as follows:
Sec. 522.313 Ceftiofur sterile powder for injection.
* * * * *
(d) * * *
(5) Dogs--(i) Amount. 1.0 milligrams per pound (2.2 milligrams per
kilogram) of body weight.
(ii) Indications for use. Treatment of canine urinary tract
infections associated with Escherichia coli and Proteus mirabilis.
(iii) Limitations. For subcutaneous use only. Treatment should be
repeated at 24-hour intervals, continued for 48 hours after clinical
signs have disappeared, for 5 to 14 days. Do not use in animals found
to be hypersensitive to the drug. Federal law restricts this drug to
use by or on the order of a licensed veterinarian.
Dated: October 25, 1994.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 94-27069 Filed 10-31-94; 8:45 am]
BILLING CODE 4160-01-F
