[Federal Register Volume 63, Number 160 (Wednesday, August 19, 1998)]
[Rules and Regulations]
[Pages 44384-44385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22226]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 524
Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin
Topical Solution
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 use of ivermectin topical (pour-on) solution on cattle for
the treatment and control of worms, grubs, lice, mites, and flies.
EFFECTIVE DATE: August 19, 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-
219 that provides for the topical use of PhoenectinTM Pour-
On (5 milligrams of ivermectin per milliliter) for cattle for the
treatment and control of gastrointestinal roundworms (including
inhibited Ostertagia ostertagi), lungworms, grubs, horn flies, sucking
and biting lice, and sarcoptic mange mites.
Phoenix Scientific, Inc.'s ANADA 200-219 ivermectin topical (pour-
on) solution for cattle is approved as a generic copy of Merial, Ltd.'s
NADA 140-841 Ivomec (ivermectin) Pour-On for Cattle. The
ANADA is approved as of July 6, 1998, and 21 CFR 524.1193(b) and (d)(2)
are amended 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 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 524
Animal drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner
[[Page 44385]]
of Food and Drugs and redelegated to the Center for Veterinary
Medicine, 21 CFR part 524 is amended as follows:
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
2. Section 524.1193 is amended by revising paragraphs (b) and
(d)(2) to read as follows:
Sec. 524.1193 Ivermectin pour-on.
* * * * *
(b) Sponsors. (1) See No. 050604 in Sec. 510.600(c) of this
chapter for use as in paragraph (d) of this section.
(2) See No. 059130 for use as in paragraphs (d)(1), (d)(2)(i), and
(d)(3) of this section.
* * * * *
(d) * * *
(2) Indications for use. (i) For cattle: It is used for the
treatment and control of: Gastrointestinal roundworms (adults and
fourth-stage larvae) Ostertagia ostertagi (including inhibited stage),
Haemonchus placei, Trichostrongylus axei, T. colubriformis, Cooperia
spp., Oesophagostomum radiatum; (adults) O. venulosum, Strongyloides
papillosus, Trichuris spp.; lungworms (adults and fourth-stage larvae)
Dictyocaulus viviparus; cattle grubs (parasitic stages) Hypoderma
bovis, H. lineatum; mites Chorioptes bovis, Sarcoptes scabei var.
bovis; lice Linognathus vituli, Haematopinus eurysternus, Damalina
bovis, Solenoptes capillatus; horn flies Haematobia irritans.
(ii) For cattle: It is also used to control infections of
gastrointestinal roundworms O. ostertagi, O. radiatum, H. placei, T.
axei, Cooperia punctata, and C. oncophora for 14 days after treatment.
* * * * *
Dated: August 3, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-22226 Filed 8-18-98; 8:45 am]
BILLING CODE 4160-01-F
