[Federal Register Volume 76, Number 244 (Tuesday, December 20, 2011)]
[Rules and Regulations]
[Pages 78815-78816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-32526]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0003]

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Cyclosporine

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 new animal drug application 
(NADA) filed by Novartis Animal Health US, Inc. The NADA provides for 
the veterinary prescription use of cyclosporine oral solution, USP 
(MODIFIED) for the control of feline allergic dermatitis.

DATES: This rule is effective December 20, 2011.

FOR FURTHER INFORMATION CONTACT: Angela K.S. Clarke, Center for 
Veterinary Medicine (HFV-112), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, (240) 276-8318, email: 
[email protected].

SUPPLEMENTARY INFORMATION: Novartis Animal Health US, Inc., 3200 
Northline Ave., suite 300, Greensboro, NC 27408, filed NADA 141-329 
that provides for the use of ATOPICA for Cats (cyclosporine oral 
solution, USP (MODIFIED)) by veterinary prescription for the control of 
feline allergic dermatitis in cats at least 6 months of age and 
weighing at least 3 pounds. The NADA is approved as of August 8, 2011, 
and 21 CFR 520.522 is amended to reflect the approval.
    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.

    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

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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


0
2. In Sec.  520.522, revise paragraphs (a) and (d) to read as follows:


Sec.  520.522  Cyclosporine.

    (a) Specifications--(1) Each cyclosporine capsule, USP (MODIFIED) 
contains 10, 25, 50, or 100 milligrams (mg) cyclosporine.

[[Page 78816]]

    (2) Each milliliter of cyclosporine oral solution, USP (MODIFIED) 
contains 100 mg cyclosporine.
* * * * *
    (d) Conditions of use--(1) Dogs. Use capsules described in 
paragraph (a)(1) of this section as follow:
    (i) Amount. Administer 5 mg per kilogram (mg/kg) 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.
    (ii) Indications for use. For the control of atopic dermatitis in 
dogs weighing at least 4 pounds.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats. Use the solution described in paragraph (a)(2) of this 
section as follow:
    (i) Amount. Administer 7 mg/kg of body weight orally as a single 
daily dose for a minimum of 4 to 6 weeks or until resolution of 
clinical signs. Following this initial daily treatment period, the 
dosage may be tapered by decreasing the frequency of administration to 
every other day or twice weekly to maintain the desired therapeutic 
effect.
    (ii) Indications for use. For the control of feline allergic 
dermatitis in cats at least 6 months of age and weighing at least 3 
pounds.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: December 15, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-32526 Filed 12-19-11; 8:45 am]
BILLING CODE 4160-01-P