[Federal Register Volume 68, Number 133 (Friday, July 11, 2003)]
[Notices]
[Pages 41385-41386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-17638]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Notice of Approval of New Animal Drug Application; Ivermectin 
Pour-On

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is providing notice 
that in 2001 it approved a supplemental abbreviated new animal drug 
application (ANADA) filed by Phoenix Scientific, Inc. The supplemental 
ANADA provided for topical use of an ivermectin solution on cattle for 
control of certain internal parasites for 14 days after treatment. The 
applicable section of the regulation did not require amendment.

FOR FURTHER INFORMATION CONTACT:  Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: In accordance with section 512(i) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(i)) and 21 CFR 
514.105(a) and 514.106(a), FDA is providing notice that in 2001 it 
approved a supplemental ANADA that was not the subject of a final rule. 
A final rule was not published because Sec.  524.1193 (21 CFR 524.1193) 
did not require amendment.
    On May 16, 2001, FDA approved a supplement filed by Phoenix 
Scientific, Inc., 3915 South 48th St. Terrace, St. Joseph, MO 64503, to 
ANADA 200-219 for PHOENECTIN (ivermectin) Pour-On. The supplemental 
ANADA provided for topical use of a 0.5 percent ivermectin solution on 
cattle for control of infections of Ostertagia ostertagi,

[[Page 41386]]

Haemonchus placei, Trichostrongylus axei, Oesophagostomum radiatum, 
Cooperia punctata, and C. oncophora for 14 days after treatment. This 
supplemental approval was based on the expiration of marketing 
exclusivity granted the pioneer product, Merial, Ltd.'s IVOMEC Pour-On 
for Cattle, in 1997 (62 FR 38907, July 21, 1997). No new data were 
submitted. The necessary amendment to Sec.  524.1193 was made in a 
final rule (66 FR 13236, March 5, 2001) for the approval of another 
generic copy of the pioneer product.
    A freedom of information summary containing approved product 
labeling may be seen in the Division of Dockets Management (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.

    Dated: June 25, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-17638 Filed 7-10-03; 8:45 am]
BILLING CODE 4160-01-S