[Federal Register Volume 61, Number 173 (Thursday, September 5, 1996)]
[Rules and Regulations]
[Page 46719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22694]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 520


Oral Dosage Form New Animal Drugs; Sulfadimethoxine/Ormetoprim 
Tablets

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 Pfizer, Inc. The approved NADA provides for 
oral use of sulfadimethoxine/ormetoprim tablets in dogs for the 
treatment of certain bacterial skin and soft tissue infections (wounds 
and abscesses). The supplement adds the treatment of certain bacterial 
urinary tract infections. This product is limited to veterinary 
prescription use.

EFFECTIVE DATE: September 5, 1996

FOR FURTHER INFORMATION CONTACT: Sandra K. Woods, Center for Veterinary 
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1617.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017, filed supplemental NADA 100-929, which provides for oral use of 
Primor (sulfadimethoxine/ormetoprim) tablets in dogs for the 
treatment of urinary tract infections caused by Escherichia coli, 
Staphylococcus spp., and Proteus mirabilis susceptible to the 
combination of sulfadimethoxine/ormetoprim in addition to its approved 
use for skin and soft tissue infections (wounds and abscesses) caused 
by strains of S. aureus and E. coli susceptible to sulfadimethoxine/
ormetoprim. This product is limited to use by or on the order of a 
licensed veterinarian. The supplement is approved as of August 5, 1996, 
and the regulations are amended in 21 CFR 520.2220d to reflect the 
approval. The basis of 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, 12420 
Parklawn Dr., rm. 1-23, 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 supplemental approval 
qualifies for 3 years of marketing exclusivity beginning August 5, 
1996, because the supplement 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. Marketing 
exclusivity applies only to use in treating urinary tract infections.
    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 520

    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 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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


Sec. 520.2220d  [Amended]

    2. Section 520.2220d Sulfadimethoxine-ormetoprim tablets is amended 
in paragraph (c)(2) by adding the phrase ``and urinary tract infections 
caused by Escherichia coli, Staphlococcus spp., and Proteus mirabilus'' 
after ``Escherichia coli'' .

    Dated: August 23, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-22694 Filed 9-4-96; 8:45 am]
BILLING CODE 4160-01-F