Document ID: FDA-2008-N-0039-0071
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs; Tulathromycin
Posted Date: 2008-10-08T04:00Z

[Federal Register: October 8, 2008 (Volume 73, Number 196)]
[Rules and Regulations]               
[Page 58872-58873]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08oc08-4]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2008-N-0039]

 
Implantation or Injectable Dosage Form New Animal Drugs; 
Tulathromycin

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 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 bovine foot rot (interdigital necrobacillosis) in 
beef and non-lactating dairy cattle.

DATES:  This rule is effective October 8, 2008.

FOR FURTHER INFORMATION CONTACT: Donald A. Prater, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8343, e-mail: 
donald.prater@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 treatment of 
bovine foot rot (interdigital necrobacillosis) associated with 
Fusobacterium necrophorum and Porphyromonas levii in beef and non-
lactating dairy cattle. The application is approved as of August 28, 
2008, 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 3 years of marketing exclusivity apply only to the bovine 
foot rot indication for which this supplement is approved.
    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 paragraph (d)(1)(ii) to read as follows:

[[Page 58873]]

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 (IBK) associated 
with Moraxella bovis. For the treatment of bovine foot rot 
(interdigital necrobacillosis) associated with Fusobacterium 
necrophorum and Porphyromonas levii.
* * * * *

    Dated: September 29, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-23832 Filed 10-7-08; 8:45 am]

BILLING CODE 4160-01-S