[Federal Register Volume 68, Number 182 (Friday, September 19, 2003)]
[Rules and Regulations]
[Page 54804]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-23944]



[[Page 54804]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Cyclosporine

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 new animal drug application 
(NADA) filed by Novartis Animal Health US, Inc. The NADA provides for 
the veterinary prescription use of cyclosporine by oral capsule for the 
control of atopic dermatitis in dogs.

DATES: This rule is effective September 19, 2003.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7543, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Novartis Animal Health US, Inc., 3200 
Northline Ave., suite 300, Greensboro, NC 27408, filed NADA 141-218 
that provides for the veterinary prescription use of ATOPICA 
(cyclosporine) Capsules for the control of atopic dermatitis in dogs 
weighing at least 4 pounds body weight. The NADA is approved as of 
August 15, 2003, and part 520 (21 CFR part 520) is amended by adding 
new Sec.  520.522 to reflect the approval. The basis of approval is 
discussed in the freedom of information summary.
    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)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 
3 years of marketing exclusivity beginning August 15, 2003.
    The agency has determined under 21 CFR 25.33(d)(1) 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. Section 520.522 is added to read as follows:


Sec.  520.522  Cyclosporine.

    (a) Specifications. Each capsule contains 10, 25, 50, or 100 
milligrams (mg) cyclosporine.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use in dogs--(1) Amount. 5 mg per kilogram of 
body weight given orally as a single daily dose for 30 days. Following 
this initial daily treatment period, the dosage may be tapered by 
decreasing the frequency of administration to every other day or two 
times a week, until a minimum frequency is reached which will maintain 
the desired therapeutic effect.
    (2) Indications for use. For the control of atopic dermatitis in 
dogs weighing at least 4 pounds body weight.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: September 11, 2003.
Linda Tollefson,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 03-23944 Filed 9-18-03; 8:45 am]
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