[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: 94-19932]
[[Page Unknown]]
[Federal Register: August 15, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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 intramuscularly in horses
for treatment of respiratory infections associated with Streptococcus
zooepidemicus.
EFFECTIVE DATE: August 15, 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) in horses as a 50 milligrams per
milliliter reconstituted injectable solution. The product is currently
approved for use in cattle, swine, and day-old chicks. The supplemental
NADA is approved as of July 13, 1994, and the regulations are amended
in 21 CFR 522.313 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 July 13, 1994, because
the application contains reports of new clinical or field
investigations (other than bioequivalence or residue 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 522.313 is amended by adding new paragraph (d)(4) to
read as follows:
Sec. 522.313 Ceftiofur sterile powder for injection.
* * * * *
(d) * * *
(4) Horses--(i) Amount. 2.2 to 4.4 milligrams per kilogram (1.0 to
2.0 milligrams per pound) of body weight.
(ii) Indications for use. For treatment of respiratory infections
in horses associated with Streptococcus zooepidemicus.
(iii) Limitations. For intramuscular use only. Treatment should be
repeated every 24 hours, continued for 48 hours after clinical signs
have disappeared, and should not exceed 10 days. A maximum of 10
milliliters should be administered per injection site. Not for use in
horses intended for food. Do not use in animals previously found to be
hypersensitive to the drug. 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. 94-19932 Filed 8-12-94; 8:45 am]
BILLING CODE 4160-01-F
