[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
PhoenectinTM 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
