[Federal Register Volume 66, Number 86 (Thursday, May 3, 2001)]
[Notices]
[Pages 22235-22236]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11071]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0183]


Elanco Animal Health, A Div. of Eli Lilly & Co. et al.; 
Withdrawal of Approval of NADAs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 13 new animal drug applications (NADAs) listed below at the request 
of the sponsor. In a final rule published elsewhere in this issue of 
the Federal Register, FDA is amending the animal drug regulations by 
removing the portions reflecting approval of the NADAs.

DATES: Withdrawal of approval is effective May 14, 2001.

FOR FURTHER INFORMATION CONTACT: Pamela K. Esposito, Center for 
Veterinary Medicine (HFV-210), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-5593.

SUPPLEMENTARY INFORMATION: The following sponsors have requested that 
FDA withdraw approval of the NADAs listed below because the products 
are no longer manufactured or marketed:

------------------------------------------------------------------------
                                                    21 CFR Cite Affected
            Sponsor                 NADA Number         (Sponsor Drug
                                  Product (Drug)        Labeler Code)
------------------------------------------------------------------------
Elanco Animal Health, A Div.    NADA 12-585 Tylan   522.2640b (000986)
 of Eli Lilly & Co., Lilly       Injectable
 Corporate Center,               (tylosin
 Indianapolis, IN 46285.         tartrate).
 .............................  NADA 15-207         522.1183(c) (000986)
                                 Hyferdex
                                 Injection (iron
                                 dextran complex).

[[Page 22236]]

 
 .............................  NADA 30-330         not applicable
                                 Tylocine Sulfa
                                 Tablets
                                 (sulfadiazine,
                                 sulfamerazine,
                                 sulfamethazine,
                                 tylosin).
 .............................  NADA 31-962 Tylan   524.2640 (000986)
                                 plus Neomycin Eye
                                 Powder (neomycin
                                 sulfate, tylosin).
 .............................  NADA 40-123 Toptic  524.321 (000986)
                                 Ointment
                                 (cephalonium,
                                 flumethasone,
                                 iodochlorhydroxyq
                                 uin, piperocaine
                                 hydrochloride,
                                 polymyxin B
                                 sulfate).
 .............................  NADA 47-092         520.2460a (000986)
                                 Tribodine
                                 (ticarbodine).
 .............................  NADA 47-353 Ferti-  522.1081(b) (000986)
                                 Cept (chorionic
                                 gonadotropin).
 .............................  NADA 92-602         529.360 (000986)
                                 Cephalothin Discs
                                 (cephaloridine).
 .............................  NADA 96-678         520.2460b (000986)
                                 Tribodine
                                 Capsules
                                 (ticarbodine).
Bioproducts, Inc., 320          NADA 93-518         558.625(b)(2)
 Springside Dr., suite 300,      Tylan     (051359)
 Fairlawn, OH 44333-2435.        10 Plus (tylosin
                                 phosphate).
Young's Inc., Roaring Spring,   NADA 96-162 Hog     558.625(b)(13)
 PA 16673.                       Grow-R-Mix-4000,    (035393)
                                 Hog Grow-R-Mix-
                                 800 (tylosin
                                 phosphate).
Veterinary Laboratories, Inc.,  NADA 42-889         522.1680(b) (000857)
 12340 Santa Fe Dr., Lenexa,     Oxytocin
 KS 66215.                       Injection
                                 (oxytocin).
Webel Feeds, Inc., R.R. 3,      NADA 116-196 Webel  558.625(b)(73)
 Pittsfield, IL 62363.           Tylan Premix        (035098)
                                 (tylosin
                                 phosphate).
------------------------------------------------------------------------

    Therefore, under authority delegated to the Commissioner of Food 
and Drugs (21 CFR 5.10), 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 NADAs 12-585, 15-207, 30-330, 31-962, 40-123, 42-889, 47-
092, 47-353, 92-602, 93-518, 96-162, 96-678, and 116-196, and all 
supplements and amendments thereto, is hereby withdrawn, effective May 
14, 2001.
    In a final rule published elsewhere in this issue of the Federal 
Register, FDA is amending the animal drug regulations by removing those 
portions that reflect approval of the NADAs.

    Dated: April 23, 2001.
Linda Tollefson,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 01-11071 Filed 5-2-01; 8:45 am]
BILLING CODE 4160-01-S