[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]
BILLING CODE 4160-01-F
