[Federal Register Volume 59, Number 72 (Thursday, April 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9048]
[[Page Unknown]]
[Federal Register: April 14, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Enalapril Maleate 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 the approval of a new animal drug
application (NADA) filed by Merck Research Laboratories, Division of
Merck & Co., Inc. The NADA provides for the oral use of ENACARDTM
(enalapril maleate) tablets for the treatment of heart failure in dogs.
EFFECTIVE DATE: April 14, 1994.
FOR FURTHER INFORMATION CONTACT: Marcia K. Larkins, Center for
Veterinary Medicine (HFV-112), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-0614.
SUPPLEMENTARY INFORMATION: Merck Research Laboratories, Division of
Merck & Co., Inc., P.O. Box 2000, Rahway, NJ 07065, filed NADA 141-015
which provides for the use of ENACARDTM containing 1, 2.5, 5, 10,
or 20 milligrams (mg) of enalapril maleate per (/) tablet.
ENACARDTM tablets are administered to dogs once daily at a dosage
of 0.5 mg/kilogram (kg) or twice daily at 0.5 mg/kg for a total daily
dose of 1.0 mg/kg for the treatment of mild, moderate, and severe
(modified New York Heart Association Class II, III, IV) heart failure
in dogs. The NADA is approved as of February 24, 1994, and the
regulations are amended in part 558 (21 CFR part 558) by adding new
Sec. 520.804 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 part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (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 Dockets
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
Section 512(c)(2)(F)(i) of the Federal Food, Drug, and Cosmetic
Act provides a 5-year period of exclusivity to this original NADA
beginning February 24, 1994, because no active ingredient (including
any ester or salt of the active ingredient) has been approved in any
other application under section 512(b)(1) of the act.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
2. New Sec. 520.804 is added to read as follows:
Sec. 520.804 Enalapril tablets.
(a) Specifications. Each tablet contains either 1.0, 2.5, 5.0,
10.0, or 20.0 milligrams of enalapril maleate.
(b) Sponsor. See 000006 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Dogs. (i) Amount. 0.5 to 1.0 milligram
of enalapril maleate per kilogram of body weight per day.
(ii) Indications for use. Treatment of mild, moderate, and severe
(modified New York Heart Association Class II, III, IV) heart failure
in dogs.
(iii) Limitations. Use 0.5 milligram per kilogram once daily. In
the absence of adequate clinical response within a 2-week period, use
may be increased to twice daily (a total of 1.0 milligram per
kilogram). Enalapril maleate is administered as conjunctive therapy
with furosemide and digoxin in the treatment of dilated cardiomyopathy
and furosemide with or without digoxin in the treatment of chronic
valvular disease. The safety of enalapril for use in breeding dogs has
not been established. Use in pregnant bitches is not recommended.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
(2) [Reserved]
Dated: April 8, 1994.
Richard H. Teske,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 94-9048 Filed 4-13-94; 8:45 am]
BILLING CODE 4160-01-F