[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: 94-26377]


[[Page Unknown]]

[Federal Register: October 25, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0202]

 

SmithKline Beecham Animal Health, et al.; Withdrawal of Approval 
of NADA's

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of three new animal drug applications (NADA's) and those portions of a 
fourth NADA providing for the use of nitrofurazone solution drug 
products. This action is being taken at the written request of the 
sponsors. In a final rule published elsewhere in this issue of the 
Federal Register, FDA is amending the regulations by removing the 
entries which reflect approval of the NADA's.

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: FDA is withdrawing approval of three NADA's 
and those portions of a fourth NADA (6-475) providing for the use of 
nitrofurazone solution drug products. 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.
    One of the requirements of the Federal Food, Drug, and Cosmetic Act 
for receiving approval of a new animal drug is that the conditions of 
use prescribed, recommended, or suggested in the proposed labeling are 
reasonably certain to be followed in practice (21 U.S.C. 360b (c)(2)). 
New information has established that the labeled directions for use of 
the nitrofurazone solution products have not been followed in practice. 
When FDA informed the products' sponsors of this situation, they 
requested voluntary withdrawal of approval of their applications. By so 
doing they have waived their right to a hearing.
    The withdrawals of approval are effective November 3, 1994. All 
manufacturing of the products must cease on this date. FDA, however, 
will exercise its enforcement discretion and will not take regulatory 
action, based on lack of approval, against the subject products if 
distributed from sponsor-owned facilities through December 31, 1994, 
and used before their expiration date.
    Therefore, under authority delegated to the Commissioner of Food 
and Drugs (21 CFR 5.10) and redelegated to the Center for Veterinary 
Medicine (21 CFR 5.84), and in accordance with Sec. 514.115 Withdrawal 
of approval of applications (21 CFR 514.115), notice is given that 
approval of NADA's 121-559, 126-023, and 126-950 and those portions of 
NADA 6-475 providing for the use of nitrofurazone solution drug 
products and all supplements and amendments thereto is hereby 
withdrawn, effective November 3, 1994. This withdrawal of approval does 
not affect the nitrofurazone-containing ointment and soluble powder 
products covered by NADA 6-475.
    In a final rule published elsewhere in the issue of the Federal 
Register, FDA is removing and reserving Sec. 524.1580d which reflects 
the approval of the NADA's.

    Dated: September 21, 1994.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 94-26377 Filed 10-24-94; 8:45 am]
BILLING CODE 4160-01-F