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). In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the regulations to remove portions reflecting approval of these NADAs.
DATES:
Withdrawal of approval is effective April 11, 2011.
FOR FURTHER INFORMATION CONTACT:
John Bartkowiak, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9079, e-mail: john.bartkowiak@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
The sponsors of the 13 approved NADAs listed in table 1 have requested that FDA withdraw approval because the products are no longer manufactured or marketed.
Table 1—Voluntary Requests for Withdrawal of Approval of 13 NADAs
| Sponsor | NADA No. Product (Established Name of Drug) | 21 CFR Section Affected (Sponsor's Drug Labeler Code) |
|---|---|---|
| Roche Vitamins, Inc., 45 Waterview Blvd., Parsippany, NJ 07054-1298 | NADA 093-029 UNITOP Cream (cuprimyxin) | 524.520 (063238) |
| Quali-Tech Products, Inc., 318 Lake Hazeltine Dr., Chaska, MN 55318 | NADA 097-981 TYLAN 40 Sulfa-G Premix (tylosin phosphate/sulfamethazine) | 558.630 (016968) |
| Abraxis Pharmaceutical Products, Division of Abraxis Bioscience, 6133 River Rd., suite 500, Rosemont, IL 60018 | NADA 100-840 Chorionic Gonadotropin for Injection (chorionic gonadotropin) | 522.1081 (063323) |
| Furst-McNess Co., Freeport, IL 61032 | NADA 100-991 McNess Custom Premix L200 (tylosin phosphate) | 558.625 (010439) |
| Fort Dodge Animal Health, Division of Wyeth Holdings, a wholly owned subsidiary of Pfizer, Inc., 235 East 42d St., New York, NY 10017 | NADA 101-079 TRAMISOL-10% Pig Wormer (levamisole) | Not codified (000856) |
| Waterloo Mills Co., 2050 Mitchell Ave., Waterloo, IA 50704 | NADA 101-905 Mill Co-Medicator TY-10 (tylosin phosphate) | 558.625 (017139) |
| Waterloo Mills Co., 2050 Mitchell Ave., Waterloo, IA 50704 | NADA 101-906 Mill Co-Medicator TS-40 Premix (tylosin phosphate/sulfamethazine) | 558.630 (017139) |
| Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514 | NADA 102-824 Phenylbutazone Tablets (phenylbutazone) | 520.1720a (055246) |
| Wendt Laboratories, Inc., 100 Nancy Dr., Belle Plaine, MN 56011 | NADA 108-487 DEC Tabs (diethylcarbamazine citrate) | 520.622a (015579) |
| Wendt Laboratories, Inc., 100 Nancy Dr., Belle Plaine, MN 56011 | NADA 108-863 DEC Chewable Tabs (diethylcarbamazine citrate) | 520.622c (015579) |
| Furst-McNess Co., Freeport, IL 61032 | NADA 140-820 TYLAN 40 Sulfa-G Premix (tylosin phosphate/sulfamethazine) | 558.630 (010439) |
| Furst-McNess Co., Freeport, IL 61032 | NADA 140-825 BANMINTH Intermediate Premix (pyrantel tartrate) | 558.485 (010439) |
| Hess & Clark, Inc., 944 Nandino Blvd., Lexington, KY 40511 | NADA 140-910 NFZ Wound Powder (nitrofurazone) | 524.1580c (050749) |
Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, and in accordance with § 514.116 Notice of withdrawal of approval of application (21 CFR 514.116), notice is given that approval of NADAs 93-029, 97-981, 100-840, 100-991, 101-079, 101-905, 101-906, 102-824, 108-487, 108-863, 140-820, 140-825, and 140-910, and all supplements and amendments thereto, is hereby withdrawn, effective April 11, 2011.
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: March 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-7558 Filed 3-30-11; 8:45 am]
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