70 FR 165 pgs. 50376-50377 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications
Type: NOTICEVolume: 70Number: 165Pages: 50376 - 50377
Docket number: [Docket No. 2005N-0149]
FR document: [FR Doc. 05-16994 Filed 8-25-05; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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: 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:
| 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.
Dated: July 5, 2005.
Linda Tollefson,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 05-16994 Filed 8-25-05; 8:45 am]
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