[Federal Register: July 11, 2003 (Volume 68, Number 133)]
[Notices]
[Page 41385-41386]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11jy03-70]
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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:
lluther@cvm.fda.gov.
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