Document ID: FDA-2009-N-0665-0053
Agency: fda
Document Type: Notice
Title: Implantation or Injectable Dosage Form New Animal Drugs; Tulathromycin
Posted Date: 2009-10-16T04:00Z

[Federal Register: October 16, 2009 (Volume 74, Number 199)]
[Rules and Regulations]               
[Page 53164-53165]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16oc09-11]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2009-N-0665]

 
Implantation or Injectable Dosage Form New Animal Drugs; 
Tulathromycin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect

[[Page 53165]]

approval of a supplemental new animal drug application (NADA) filed by 
Pfizer, Inc. The supplemental NADA provides for veterinary prescription 
use of tulathromycin injectable solution for the control of swine 
respiratory disease (SRD) in groups of pigs where SRD has been 
diagnosed.

DATES: This rule is effective October 16, 2009.

FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8341, e-mail: 
cindy.burnsteel@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) 
Injectable Solution. The supplemental NADA provides for the use of 
tulathromycin injectable solution for control of SRD associated with 
Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma 
hyopneumoniae in groups of pigs where SRD has been diagnosed. The 
application is approved as of September 8, 2009, and the regulations 
are amended in Sec.  522.2630 (21 CFR 522.2630) to reflect the 
approval.
    In addition, FDA has noticed that the approved indications for use 
of this product in cattle (73 FR 58872, October 8, 2008) were 
inaccurately codified. At this time, Sec.  522.2630 is being amended to 
correctly describe these indications for use. This action is being 
taken to improve the accuracy of the regulations.
    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(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, Histophilus somni, 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. For the 
treatment of infectious bovine keratoconjunctivitis associated with 
Moraxella bovis. For the treatment of bovine foot rot (interdigital 
necrobacillosis) associated with Fusobacterium necrophorum and 
Porphyromonas levii.
* * * * *
    (2) * * *
    (ii) Indications for use. For the treatment of swine respiratory 
disease (SRD) associated with Actinobacillus pleuropneumoniae, P. 
multocida, Bordetella bronchiseptica, Haemophilus parasuis, and 
Mycoplasma hyopneumoniae; and for the control of SRD associated with A. 
pleuropneumoniae, P. multocida, and M. hyopneumoniae in groups of pigs 
where SRD has been diagnosed.
* * * * *

    Dated: September 30, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E9-24882 Filed 10-15-09; 8:45 am]

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