[Federal Register Volume 63, Number 52 (Wednesday, March 18, 1998)]
[Rules and Regulations]
[Pages 13121-13122]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-6911]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Desoxycorticosterone Pivalate

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 
use of desoxycorticosterone pivalate as replacement therapy for the 
mineralocorticoid deficit in dogs with primary adrenocortical 
insufficiency.

EFFECTIVE DATE: March 18, 1998.

[[Page 13122]]

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1612.

SUPPLEMENTARY INFORMATION: Novartis Animal Health US, Inc., P.O. Box 
26402, Greensboro, NC 27404-6402, is the sponsor of NADA 141-029 that 
provides for the use of PercortenTM-V (desoxycorticosterone 
pivalate) as replacement therapy for the mineralocorticoid deficit in 
dogs with primary adrenocortical insufficiency. The drug is limited to 
use by or on the order of a licensed veterinarian. The NADA is approved 
as of January 12, 1998, and the regulations are amended by adding new 
21 CFR 522.535 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 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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
between 9 a.m. and 4 p.m., Monday through Friday.
    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.
    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 for nonfood-
producing animals qualifies for 5 years of marketing exclusivity 
beginning January 12, 1998, because no active ingredient of the drug 
(including any salt or ester of the active ingredient) has been 
approved in any other application.

List of Subjects in 21 CFR Part 522

    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 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

    2. New Sec. 522.535 is added to read as follows:


Sec. 522.535  Desoxycorticosterone pivalate.

    (a) Specifications. Each milliliter of sterile aqueous suspension 
contains 25 milligrams of desoxycorticosterone pivalate.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Dogs--(i) Amount. Dosage requirements 
are variable and must be individualized on the basis of the response of 
the patient to therapy. Initial dose of 1 milligram per pound (0.45 
kilogram) of body weight every 25 days, intramuscularly. Usual dose is 
0.75 to 1.0 milligram per pound of body weight every 21 to 30 days.
    (ii) Indications for use. For use as replacement therapy for the 
mineralocorticoid deficit in dogs with primary adrenocortical 
insufficiency.
    (iii) Limitations. For intramuscular use only. Do not use in 
pregnant dogs, dogs suffering from congestive heart disease, severe 
renal disease, or edema. Federal law restricts this drug to use by or 
on the order of a licensed veterinarian.
    (2) [Reserved]

    Dated: February 6, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-6911 Filed 3-17-98; 8:45 am]
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