2011-7558. Withdrawal of Approval of New Animal Drug Applications; Chorionic Gonadotropin; Cuprimyxin; Diethylcarbamazine; Levamisole; Nitrofurazone; Phenylbutazone; Pyrantel; Tylosin; Tylosin and Sulfamethazine

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: [e-mail].

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.