Food and Drug Administration, HHS.
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.
Withdrawal of approval is effective September 6, 2005.Start Further Info
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: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental 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:Start Printed Page 50377
|Sponsor||NADA Number, Product (Drug)||21 CFR Section Affected, (Sponsor Drug Labeler Code)|
|Abbott Laboratories, North Chicago, IL 60064||NADA 99-568, FURANACE Caps (nifurpirinol)||529.1526 (000074)|
|Biocraft Laboratories, Inc., 92 Route 46, Elmwood Park, NJ 07407||NADA 140-889, DERM-OTIC Ointment (neomycin sulfate, nystatin, thiostrepton, triamcinolone acetonide)||524.1600a (000332)|
|First Priority, Inc., 1585 Todd Farm Dr., Elgin, IL 60123||NADA 48-646, THERAZONE Injection (phenylbutazone)||522.1720 (058829)|
|Happy Jack, Inc., Snow Hill, NC 28580||NADA 121-556, Selenium Sulfide Suspension (selenium disulfide)||524.2101 (023851)|
|NADA 121-723, Nitrofurazone Dressing||524.1580b (023851)|
|NADA 125-137, FILARICIDE Capsules (diethylcarbamazine citrate)||520.622d (023851)|
|IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544||NADA 92-151, N-Butyl Chloride Canine Worming Caps||520.260 (000115)|
|NADA 65-065, Tetracycline HCl Caps||520.2345a (000115)|
|NADA 138-900, Dichlorophene/Toluene||520.580 (000115)|
|Jorgensen Laboratories, Inc., 1450 North Van Buren Ave., Loveland, CO 80538||NADA 10-481, SUREJETS (salacylic acid)||529.2090 (048087)|
|Pliva d.d., Ulica grada Vukovara 49, 10000 Zagreb, Croatia||ANADA, 200-232, GEOMYCIN 200 Injection (oxytetracycline)||522.1660a (011722)|
|Purina Mills, Inc., P.O. Box 66812, St. Louis, MO 63166-6812||NADA 65-113 AUREO Sulfa Soluble Powder (chlortetracycline/sulfamethazine)||N/A (017800)|
|Roche Vitamins, Inc., 45 Waterview Blvd., Parsippany, NJ 07054-1298||NADA 140-848, VETEEZE Injection (diazepam)||522.575 (063238)|
|Teva Pharmaceuticals USA, 650 Cathill Rd., Sellersville, PA 18960||NADA 131-806, Furosemide Tablets||520.1010 (000093)|
|Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137||NADA 10-886, Purina Liquid Wormer (piperazine citrate)||N/A (051311)|
|Wyeth Laboratories, Division of American Home Products Corp., P.O. Box 8299, Philadelphia, PA 19101||NADA 10-782, SPARINE Injection (promazine)||522.1962 (000008)|
|NADA 55-008, BICILLIN Fortified (penicillin G benzathine and penicillin G procaine)||522.1696a (000008)|
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 § 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.Start Signature
Dated: July 5, 2005.
Acting Director, Center for Veterinary Medicine.
[FR Doc. 05-16994 Filed 8-25-05; 8:45 am]
BILLING CODE 4160-01-S