Document ID: FDA-2010-N-0002-0081
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs: Tylosin
Posted Date: 2010-12-08T05:00Z

[Federal Register Volume 75, Number 235 (Wednesday, December 8, 2010)]
[Rules and Regulations]
[Pages 76259-76260]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30814]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2010-N-0002]

Oral Dosage Form New Animal Drugs; Tylosin

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 an original abbreviated new 
animal drug application (ANADA) filed by Huvepharma AD. The ANADA 
provides for use of tylosin tartrate soluble powder in drinking water 
of chickens, turkeys, swine, and honey bees for the treatment or 
control of various bacterial diseases.

DATES: This rule is effective December 8, 2010.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-170), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Huvepharma AD, 33 James Boucher Blvd., 
Sophia 1407, Bulgaria, filed ANADA 200-473 that provides for use of 
PHARMASIN (tylosin tartrate) Soluble in medicated drinking water for 
chickens, turkeys, swine, and honey bees for the treatment or control 
of various bacterial diseases. Huvepharma AD's PHARMASIN Soluble is 
approved as a generic copy of Elanco Animal Health's TYLAN Soluble, 
approved under NADA 13-076. The ANADA is approved as of October 1, 
2010, and the regulations in 21 CFR 520.2640 are amended 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.
    The Agency has determined under 21 CFR 25.33 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 520

    Animal drugs.

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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

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

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

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2. In Sec.  520.2640, revise paragraphs (a), (b), and (d)(3)(ii) to 
read as follows:

Sec.  520.2640  Tylosin.

    (a) Specifications. Each container contains tylosin tartrate 
equivalent to 100 grams tylosin base.
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter.
    (1) No. 000986 for use as in paragraph (d) of this section.
    (2) No. 016592 for use as in paragraphs (d)(1), (d)(2), (d)(3)(i), 
(d)(3)(ii)(B), (d)(3)(iii), and (d)(4) of this section.
* * * * *
    (d) * * *
    (3) * * *
    (ii) Indications for use--(A) For the treatment and control of 
swine dysentery associated with Brachyspira hyodysenteriae and for the 
control of porcine proliferative enteropathies (PPE, ileitis) 
associated with Lawsonia intracellularis.
    (B) For the treatment and control of swine dysentery associated 
with B. hyodysenteriae.
* * * * *

[[Page 76260]]

    Dated: December 2, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-30814 Filed 12-7-10; 8:45 am]
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