[Federal Register Volume 62, Number 205 (Thursday, October 23, 1997)]
[Rules and Regulations]
[Page 55161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-28014]
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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; Miconazole
Nitrate Lotion and Spray
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 Med-Pharmex, Inc. The ANADA provides for
use of miconazole nitrate lotion and spray as topical antifungal agents
to treat certain infections of dogs and cats.
EFFECTIVE DATE: October 23, 1997.
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: Med-Pharmex, Inc., 2727 Thompson Creek Rd.,
Pomona, CA 91767, filed ANADA 200-196, which provides for use of
miconazole nitrate lotion 1 percent and miconazole nitrate spray 1
percent as antifungal agents for topical treatment of infections in
dogs and cats caused by Microsporum canis, M. gypseum, and Trichophyton
mentagrophytes.
Med-Pharmex's ANADA 200-196 is approved as a generic copy of
Mallinckrodt Veterinary's Conofite miconazole nitrate 1
percent lotion and spray, NADA 95-184. ANADA 200-196 is approved as of
August 4, 1997, and the regulations are amended in 21 CFR 524.1443(b)
to reflect the approval. The basis for 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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857,
between 9 a.m. and 4 p.m., Monday through Friday.
The agency has determined under 21 CFR 25.33 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 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 524.1443 is amended by revising paragraph (b) to read as
follows:
Sec. 524.1443 Miconazole nitrate cream; miconazole nitrate lotion;
miconazole nitrate spray.
* * * * *
(b) Sponsor. See No. 011716 in Sec. 510.600(c) of this chapter for
use of cream, lotion, and spray; see No. 051259 in Sec. 510.600(c) of
this chapter for use of lotion and spray.
* * * * *
Dated: September 10, 1997.
Michael J. Blackwell,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 97-28014 Filed 10-22-97; 8:45 am]
BILLING CODE 4160-01-F