Document ID: FDA-2008-N-0039-0005
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs; Tulathromycin
Posted Date: 2008-02-01T05:00Z

[Federal Register: February 1, 2008 (Volume 73, Number 22)]
[Rules and Regulations]               
[Page 6017-6018]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01fe08-5]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

 
Implantation or Injectable Dosage Form New Animal Drugs; 
Tulathromycin

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 supplemental NADA provides 
for veterinarian prescription use of tulathromycin injectable solution 
for the treatment of infectious bovine keratoconjunctivitis and the 
addition of a pathogen to the indication for use for treatment of swine 
respiratory disease.

DATES:  This rule is effective February 1, 2008.

FOR FURTHER INFORMATION CONTACT:  Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8342, e-mail: 
joan.gotthardt@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017, filed a supplement to NADA 141-244 for DRAXXIN (tulathromycin)

[[Page 6018]]

Injectable Solution. The supplemental NADA provides for treatment of 
infectious bovine keratoconjunctivitis associated with Moraxella bovis 
and the addition of a pathogen, Mycoplasma hyopneumoniae, to the 
indication for use for treatment of swine respiratory disease. The 
application is approved as of December 28, 2007, and the regulations 
are amended in 21 CFR 522.2630 to reflect the 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)(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 on the date of 
approval.
    The agency has determined under 21 CFR 25.33(a)(1) and (d)(5) that 
this action is of a type that does 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.

0
2. In Sec.  522.2630, revise paragraphs (d)(1)(ii) and (d)(2)(ii) to 
read as follows:

Sec.  522.2630  Tulathromycin.

* * * * *
    (d) * * *
    (1) * * *
    (ii) Indications for use. For the treatment of bovine respiratory 
disease (BRD) associated with Mannheimia haemolytica, Pasteurella 
multocida, and Histophilus somni (Haemophilus somnus), and Mycoplasma 
bovis; for the control of respiratory disease in cattle at high risk of 
developing BRD associated with M. haemolytica, P. multocida, H. somni, 
and M. bovis; and for the treatment of infectious bovine 
keratoconjunctivitis (IBK) associated with Moraxella bovis.
* * * * *
    (2) * * *
    (ii) Indications for use. For the treatment of swine respiratory 
disease (SRD) associated with Actinobacillus pleuropneumoniae, 
Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, 
and Mycoplasma hyopneumoniae.
* * * * *

    Dated: January 24, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-1906 Filed 1-31-08; 8:45 am]

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