[Federal Register Volume 59, Number 221 (Thursday, November 17, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-28332]


[[Page Unknown]]

[Federal Register: November 17, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0219]

 

 Lemmon Co., 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) held by Lemmon Co., 
Banner Pharmacaps, Inc., and Nutra-Blend Corp. The sponsors requested 
the withdrawals of approval. 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 28, 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 
on the written request of the following sponsors: Lemmon Co., 650 
Cathill Rd., Sellersville, PA 18960, is the sponsor of NADA 65-467 that 
provides for the use of Tetracycline Hydrochloride Capsules in dogs for 
the treatment of bacterial gastroenteritis and urinary tract 
infections. Lemmon Co. requested, in its letter of May 2, 1994, that 
FDA withdraw approval of NADA 65-467 because the firm no longer 
manufactures or markets the product.
     Banner Pharmacaps, Inc. (formerly Pharmacaps, Inc.), P.O. Box 547, 
1111 Jefferson Ave., Elizabeth, NJ 07207, is the sponsor of NADA 119-
844 that provides for the use of Dichlorophene/Toluene Capsules in dogs 
and cats as an anthelmintic. Banner Pharmacaps, Inc., requested, in its 
letter of April 20, 1994, that FDA withdraw approval of NADA 119-844 
because the firm no longer manufactures or markets the product.
     Nutra-Blend Corp., Rt. 7, Box 192A, Neosho, MO 64850, is the 
sponsor of NADA 129-160 that provides for the manufacture of a Type B 
medicated feed containing 0.6 gram of hygromycin B per pound. This 
approved NADA is not required for the firm to manufacture a Type B 
medicated feed containing 0.6 gram of hygromycin B per pound. 
Accordingly, in a letter dated March 18, 1994, the firm requested that 
FDA withdraw the approval for NADA 129-160.
     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 65-467, 119-844, and 129-160, and all supplements 
and amendments thereto is hereby withdrawn, effective November 28, 
1994.
     In a final rule published elsewhere in this issue of the Federal 
Register, FDA is amending 21 CFR 520.2345a, 21 CFR 520.580, 21 CFR 
510.600(c)(1) and (c)(2), and 21 CFR 558.274 to reflect the withdrawal 
of approval of these NADA's.

    Dated: November 8, 1994.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 94-28332 Filed 11-16-94; 8:45 am]
BILLING CODE 4160-01-F