[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:
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Sponsor NADA No.
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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
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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
