[Federal Register Volume 70, Number 165 (Friday, August 26, 2005)]
[Notices]
[Pages 50376-50377]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-16994]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
[email protected].
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