Implantation or Injectable Dosage Form New Animal Drugs; Cefovecin, 29685 [E8-11515]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 73, Number 100 (Thursday, May 22, 2008)]
[Rules and Regulations]
[Page 29685]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-11515]



========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 
Prices of new books are listed in the first FEDERAL REGISTER issue of each 
week.

========================================================================


Federal Register / Vol. 73, No. 100 / Thursday, May 22, 2008 / Rules 
and Regulations

[[Page 29685]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Cefovecin

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 Pfizer, Inc. The NADA provides for the veterinary 
prescription use of a solution of cefovecin sodium in cats and dogs by 
subcutaneous injection for the treatment of skin infections.

DATES: This rule is effective May 22, 2008.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail: 
melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017, filed NADA 141-285 that provides for the veterinary prescription 
use of CONVENIA (cefovecin sodium) Injectable in cats and dogs by 
subcutaneous injection for the treatment of skin infections. The 
application is approved as of April 25, 2008, and the regulations are 
amended in 21 CFR part 522 to reflect approval.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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 Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 
5 years of marketing exclusivity beginning on the date of approval.
    The agency has determined under 21 CFR 25.33(d)(1) that these 
actions are of a type that do not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 522

    Animal drugs.

0
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

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.


Sec.  522.311  [Redesignated as Sec.  522.300]

0
2. Redesignate Sec.  522.311 as Sec.  522.300.


Sec.  522.312  [Redesignated as Sec.  522.304]

0
3. Redesignate Sec.  522.312 as Sec.  522.304.

0
4. Add new Sec.  522.311 to read as follows:


Sec.  522.311  Cefovecin.

    (a) Specifications. Each milliliter of constituted solution 
contains 80 milligrams (mg) cefovecin as the sodium salt.
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) Conditions of use--(1) Dogs--(i) Amount. Administer 3.6 mg/
pound (lb) (8 mg/kilograms (kg)) body weight as a single subcutaneous 
injection. A second subcutaneous injection of 3.6 mg/lb (8 mg/kg) may 
be administered if response to therapy is not complete.
    (ii) Indications for use. For the treatment of skin infections 
(secondary superficial pyoderma, abscesses, and wounds) in dogs caused 
by susceptible strains of Staphylococcus intermedius and Streptococcus 
canis (Group G).
    (2) Cats--(i) Amount. Administer 3.6 mg/lb (8 mg/kg) body weight as 
a single, one-time subcutaneous injection.
    (ii) Indications for use. For the treatment of skin infections 
(wounds and abscesses) in cats caused by susceptible strains of 
Pasteurella multocida.

    Dated: May 13, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-11515 Filed 5-21-08; 8:45 am]
BILLING CODE 4160-01-S