Federal Register, Volume 63 Issue 137 (Friday, July 17, 1998)

[Federal Register Volume 63, Number 137 (Friday, July 17, 1998)]
[Rules and Regulations]
[Pages 38473-38474]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19028]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Ivermectin Liquid

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 an abbreviated new animal drug 
application (ANADA) filed by Phoenix Scientific, Inc. The ANADA 
provides for veterinary prescription use of ivermectin oral liquid in 
horses to treat and control parasites and parasitic conditions.

EFFECTIVE DATE: July 17, 1998.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
St. Terrace, P.O. Box 6457, St. Joseph, MO 64506-0457, filed ANADA 200-
202 that provides for veterinary prescription use of 
Phoenectin^TM Liquid (10 milligram per milliliter (mg/mL) 
ivermectin oral liquid) for horses for the treatment and control of 
infections of large strongyles (adult) (Strongylus equinus), (adult and 
arterial larval stages) (S. vulgaris), (adult and migrating tissue 
stages) (S. endentatus), (adult) (Triodontophorus spp.); small 
strongyles, including those resistant to some benzimidizole class 
compounds (adults and fourth-stage larvae) (Cyathostomum spp.,

[[Page 38474]]

Cylicocyclus spp., Cylicodontophorus spp., (Cylicostephanus spp.), 
pinworms (adult and fourth-stage larvae) (Oxyuris equi); ascarids 
(third- and fourth-stage larvae and adults) (Parascaris equorum); 
hairworms (adult) (Trichostrongylus axei); large-mouth stomach worms 
(adult) (Habronema muscae); stomach bots (oral and gastric stages) 
(Gastrophilus spp.); lungworms (adults and forth-stage larvae) 
(Dictyocaulus arnfieldi); intestinal threadworms (adults) 
(Strongyloides westeri); summer sores caused by Habronema and Draschia 
spp. cutaneous third-stage larvae; and dermatitis caused by neck 
threadworm microfilariae (Onchocerca spp.).
    Approval of ANADA 200-202 for Phoenix Scientific, Inc.'s, 
ivermectin oral liquid is as a generic copy of Merial Ltd.'s, NADA 140-
439 Eqvalan  (ivermectin) liquid for horses. The ANADA is 
approved as of June 5, 1998, and the regulations are amended in 21 CFR 
520.1195(b) 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 Sec. 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, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33(a)(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.

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: 21 U.S.C. 360b.


Sec. 520.1195  [Amended]

    2. Section 520.1195 Ivermectin liquid is amended in paragraph (b) 
by removing ``No. 050604'' and adding in its place ``Nos. 050604 and 
059130''.

    Dated: July 9, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-19028 Filed 7-16-98; 8:45 am]
BILLING CODE 4160-01-F