[Federal Register Volume 59, Number 205 (Tuesday, October 25, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-26376]


[[Page Unknown]]

[Federal Register: October 25, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 524

[Docket No. 94N-0202]

 

Nitrofurazone Solution; Removal of Regulation

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is removing the 
regulation which reflects approval of three new animal drug 
applications (NADA's) providing for the use of nitrofurazone solution 
drug products. Additionally, approval of those portions of a fourth 
NADA (sponsored by SmithKline Beecham Animal Health) which provide for 
use of nitrofurazone solution product is also being withdrawn, but that 
approval is not codified. All four sponsors submitted written requests 
that the agency withdraw the approvals.

EFFECTIVE DATE: November 3, 1994.

FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for 
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-0749.

SUPPLEMENTARY INFORMATION:  In a notice published elsewhere in this 
issue of the Federal Register, FDA is withdrawing approval of three 
NADA's and those portions of NADA 6-475 providing for the use of 
nitrofurazone solution. The withdrawals of approval were requested in 
writing by the sponsors after FDA informed them that new information 
establishes that the labeled directions for use of the 0.2 percent 
nitrofurazone solutions have not been followed in practice. The NADA's 
are:

------------------------------------------------------------------------
         Sponsor                             NADA No.                   
------------------------------------------------------------------------
SmithKline Beecham                                                      
 Animal Health, 1600                                                    
 Paoli Pike, West                                                       
 Chester, PA 19380                                                6-475 
Veterinary Laboratories,                                                
 Inc., 12340 Santa Fe                                                   
 Dr., Lenexa, KS 66215                                          121-559 
Fermenta Animal Health                                                  
 Co., 10150 North                                                       
 Executive Hills Blvd.,                                                 
 Kansas City, MO 64153                                          126-023 
Med-Pharmex, Inc.,                                                      
 Biomed Laboratories,                                                   
 325 East Arrow Hwy.,                                                   
 San Dimas, CA 91773                                            126-950 
------------------------------------------------------------------------

    The NADA's provide for over-the-counter use of 0.2 percent 
nitrofurazone solution on dogs, cats, and horses for prevention or 
treatment of topical bacterial infections, and prescription use for 
female equine genital tract infections and impaired fertility due to 
strains of certain bacteria. This document removes 21 CFR 524.1580d, 
the regulation which reflects the approvals.

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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).



Sec. 524.1580d  [Removed]

    2. Section 524.1580d Nitrofurazone solution is removed and 
reserved.

    Dated: September 21, 1994.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 94-26376 Filed 10-24-94; 8:45 am]
BILLING CODE 4160-01-F