[Federal Register Volume 60, Number 185 (Monday, September 25, 1995)]
[Rules and Regulations]
[Pages 49339-49340]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23603]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Melarsomine Dihydrochloride for Injection

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 Rhone Merieux, Inc. The NADA provides for intramuscular 
use of injectable melarsomine dihydrochloride for the treatment of 
heartworm disease in dogs.

EFFECTIVE DATE: September 25, 1995.

FOR FURTHER INFORMATION CONTACT: Marcia K. Larkins, Center for 
Veterinary Medicine (HFV-112), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0137.

SUPPLEMENTARY INFORMATION: Rhone Merieux, Inc., 7101 College Blvd., 
suite 610, Overland Park, KS 66210, filed NADA 141-042 to provide for 
intramuscular use of the injectable drug product Immiticide Sterile 
Powder which consists of a vial of lyophilized powder containing 50 
milligrams of melarsomine dihydrochloride to be reconstituted with the 
provided 2 milliliters of sterile water. The drug is indicated for the 
treatment of stabilized, class 1, 2, and 3 heartworm disease 
(asymptomatic to mild, moderate, and severe, respectively) caused by 
immature (4 month-old, stage L5) to mature adult infections of 
Dirofilaria immitis in dogs. The drug product is available by 
prescription. The NADA is approved as of July 21, 1995, and the 
regulations are amended in part 522 (21 CFR part 522) by adding new 
Sec. 522.1362 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.
    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 
5 years of marketing exclusivity beginning July 21, 1995, because no 
active ingredient 

[[Page 49340]]
(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 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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

    2. New Sec. 522.1362 is added to read as follows:


Sec. 522.1362  Melarsomine dihydrochloride for injection.

    (a) Specifications. The drug consists of a vial of lyophilized 
powder containing 50 milligrams of melarsomine dihydrochloride which is 
reconstituted with the provided 2 milliliters of sterile water for 
injection.
    (b) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. For asymptomatic to moderate 
(class 1 to class 2) heartworm disease: 2.5 milligrams per kilogram of 
body weight (1.1 milligram per pound) twice, 24 hours apart. The series 
can be repeated in 4 months depending on the response to the first 
treatment and the condition, age, and use of the dog. For severe (class 
3) heartworm disease: Single injection of 2.5 milligrams per kilogram 
followed, approximately 1 month later, by 2.5 milligrams per kilogram 
administered twice, 24 hours apart.
    (2) Indications. Treatment of stabilized, class 1, 2, and 3 
heartworm disease (asymptomatic to mild, moderate, and severe, 
respectively) caused by immature (4 month-old, stage L5) to mature 
adult infections of Dirofilaria immitis in dogs.
    (3) Limitations. Administer only by deep intramuscular injection in 
the lumbar muscles (L3-L5). Use a 23 gauge 1 inch needle for 
dogs less than or equal to 10 kilograms (22 pounds) and a 22 gauge 1 1/
2 inch needle for dogs greater than 10 kilograms (22 pounds). Use 
alternate sides with each administration. The drug is contraindicated 
in dogs with class 4 (very severe) heartworm disease (Caval Sydrome). 
Not for use in breeding animals and lactating or pregnant bitches. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

    Dated: September 1, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-23603 Filed 9-22-95; 8:45 am]
BILLING CODE 4160-01-F