[Federal Register: September 19, 2003 (Volume 68, Number 182)]
[Rules and Regulations]
[Page 54804]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19se03-5]
[[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:
mberson@cvm.fda.gov.
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.
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 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. 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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