[Federal Register Volume 64, Number 7 (Tuesday, January 12, 1999)]
[Rules and Regulations]
[Pages 1761-1762]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-639]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Clomipramine Hydrochloride 
Tablets

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 
oral veterinary prescription use of clomipramine hydrochloride tablets 
to be used as part of a comprehensive behavioral management program to 
treat separation anxiety in dogs greater than 6 months of age.

EFFECTIVE DATE: January 12, 1999.
FOR FURTHER INFORMATION CONTACT:  Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7540.

SUPPLEMENTARY INFORMATION:  Novartis Animal Health US, Inc., P.O. Box 
18300, Greensboro, NC 27419-8300, filed NADA 141-120 that provides for 
oral veterinary prescription administration of ClomicalmTM 
(clomipramine hydrochloride) tablets at 2 to 4 milligrams (mg)/kilogram 
body weight per day (0.9 to 1.8 mg per pound per day) administered as a 
single daily dose or divided twice daily to dogs greater than 6 months 
of age. The NADA is approved as of December 10, 1998, and the 
regulations are amended in 21 CFR

[[Page 1762]]

part 520 by adding new Sec. 520.455 to reflect the approval. The basis 
for approval is discussed in the freedom of information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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 Dockets Management Branch (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)(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 
a 5-year period of marketing exclusivity beginning December 10, 1998, 
because no active ingredient (including any ester or salt of the active 
ingredient) has been approved in any other application.
    FDA 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.

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

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

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

    2. Section 520.455 is added to read as follows:


Sec. 520.455   Clomipramine hydrochloride tablets.

    (a) Specifications. Each tablet contains 20, 40, or 80 milligrams 
of clomipramine hydrochloride.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 2 to 4 milligrams of 
clomipramine hydrochloride per kilogram (0.9 to 1.8 milligrams per 
pound) of body weight per day, administered as a single daily dose or 
divided twice daily.
    (2) Indications for use. For use as part of a comprehensive 
behavioral management program to treat separation anxiety in dogs 
greater than 6 months of age.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: January 4, 1999.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 99-639 Filed 1-11-99; 8:45 am]
BILLING CODE 4160-01-F