[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