[Federal Register: August 26, 2005 (Volume 70, Number 165)]
[Notices]               
[Page 50376-50377]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26au05-104]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0149]

 
Animal Drugs, Feeds, and Related Products; Withdrawal of Approval 
of New Animal Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 16 new animal drug applications (NADAs) and 1 abbreviated NADA 
(ANADA) because the products are no longer manufactured or marketed. In 
a final rule published elsewhere in this issue of the Federal Register, 
FDA is amending the animal drug regulations to remove portions 
reflecting approval of the NADAs.

DATES: Withdrawal of approval is effective September 6, 2005.

FOR FURTHER INFORMATION CONTACT: Pamela K. Esposito, Center for 
Veterinary Medicine (HFV-210), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-7818, or e-mail: 
pesposit@cvm.fda.gov.


SUPPLEMENTARY INFORMATION: The following sponsors have requested that 
FDA withdraw approval of the 16 NADAs and 1 ANADA listed in table 1 of 
this document because the products are no longer manufactured or 
marketed:

[[Page 50377]]



                                Table 1.
------------------------------------------------------------------------
                                                          21 CFR Section
                                                            Affected,
        Sponsor           NADA Number, Product (Drug)     (Sponsor Drug
                                                          Labeler Code)
------------------------------------------------------------------------
Abbott Laboratories,    NADA 99-568, FURANACE Caps       529.1526
 North Chicago, IL       (nifurpirinol)                   (000074)
 60064
------------------------------------------------------------------------
Biocraft Laboratories,  NADA 140-889, DERM-OTIC          524.1600a
 Inc., 92 Route 46,      Ointment (neomycin sulfate,      (000332)
 Elmwood Park, NJ        nystatin, thiostrepton,
 07407                   triamcinolone acetonide)
------------------------------------------------------------------------
First Priority, Inc.,   NADA 48-646, THERAZONE           522.1720
 1585 Todd Farm Dr.,     Injection (phenylbutazone)       (058829)
 Elgin, IL 60123
------------------------------------------------------------------------
Happy Jack, Inc., Snow  NADA 121-556, Selenium Sulfide   524.2101
 Hill, NC 28580          Suspension (selenium             (023851)
                         disulfide)
                        NADA 121-723, Nitrofurazone      524.1580b
                         Dressing                         (023851)
                        NADA 125-137, FILARICIDE         520.622d
                         Capsules (diethylcarbamazine     (023851)
                         citrate)
------------------------------------------------------------------------
IMPAX Laboratories,     NADA 92-151, N-Butyl Chloride    520.260
 Inc., 30831 Huntwood    Canine Worming Caps              (000115)
 Ave., Hayward, CA
 94544
                        NADA 65-065, Tetracycline HCl    520.2345a
                         Caps                             (000115)
                        NADA 138-900, Dichlorophene/     520.580
                         Toluene                          (000115)
------------------------------------------------------------------------
Jorgensen               NADA 10-481, SUREJETS            529.2090
 Laboratories, Inc.,     (salacylic acid)                 (048087)
 1450 North Van Buren
 Ave., Loveland, CO
 80538
------------------------------------------------------------------------
Pliva d.d., Ulica       ANADA, 200-232, GEOMYCIN 200     522.1660a
 grada Vukovara 49,      Injection (oxytetracycline)      (011722)
 10000 Zagreb, Croatia
------------------------------------------------------------------------
Purina Mills, Inc.,     NADA 65-113 AUREO Sulfa Soluble  N/A (017800)
 P.O. Box 66812, St.     Powder (chlortetracycline/
 Louis, MO 63166-6812    sulfamethazine)
------------------------------------------------------------------------
Roche Vitamins, Inc.,   NADA 140-848, VETEEZE Injection  522.575
 45 Waterview Blvd.,     (diazepam)                       (063238)
 Parsippany, NJ 07054-
 1298
------------------------------------------------------------------------
Teva Pharmaceuticals    NADA 131-806, Furosemide         520.1010
 USA, 650 Cathill Rd.,   Tablets                          (000093)
 Sellersville, PA
 18960
------------------------------------------------------------------------
Virbac AH, Inc., 3200   NADA 10-886, Purina Liquid       N/A (051311)
 Meacham Blvd., Ft.      Wormer (piperazine citrate)
 Worth, TX 76137
------------------------------------------------------------------------
Wyeth Laboratories,     NADA 10-782, SPARINE Injection   522.1962
 Division of American    (promazine)                      (000008)
 Home Products Corp.,
 P.O. Box 8299,
 Philadelphia, PA
 19101
                        NADA 55-008, BICILLIN Fortified  522.1696a
                         (penicillin G benzathine and     (000008)
                         penicillin G procaine)
------------------------------------------------------------------------

    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 10-481, 10-782, 10-886, 48-646, 55-008, 65-065, 65-
113, 99-568, 121-556, 121-723, 125-137, 131-806, 138-900, 140-848, 140-
889, and ANADA 200-232, and all supplements and amendments thereto, is 
hereby withdrawn, effective September 6, 2005.
    In a final rule published elsewhere in this issue of the Federal 
Register, FDA is amending the animal drug regulations to reflect the 
withdrawal of approval of these NADAs.

    Dated: July 5, 2005.
Linda Tollefson,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 05-16994 Filed 8-25-05; 8:45 am]

BILLING CODE 4160-01-S