# 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: *[email protected].*
**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.
| 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 | 524.520 |
| Quali-Tech Products, Inc., 318 Lake Hazeltine Dr., Chaska, MN 55318 | NADA 097-981 | 558.630 |
| Abraxis Pharmaceutical Products, Division of Abraxis Bioscience, 6133 River Rd., suite 500, Rosemont, IL 60018 | NADA 100-840 | 522.1081 |
| Furst-McNess Co., Freeport, IL 61032 | NADA 100-991 | 558.625 |
| 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 | Not codified |
| Waterloo Mills Co., 2050 Mitchell Ave., Waterloo, IA 50704 | NADA 101-905 | 558.625 |
| Waterloo Mills Co., 2050 Mitchell Ave., Waterloo, IA 50704 | NADA 101-906 | 558.630 |
| Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514 | NADA 102-824 | 520.1720a |
| Wendt Laboratories, Inc., 100 Nancy Dr., Belle Plaine, MN 56011 | NADA 108-487 | 520.622a |
| Wendt Laboratories, Inc., 100 Nancy Dr., Belle Plaine, MN 56011 | NADA 108-863 | 520.622c |
| Furst-McNess Co., Freeport, IL 61032 | NADA 140-820 | 558.630 |
| Furst-McNess Co., Freeport, IL 61032 | NADA 140-825 | 558.485 |
| Hess & Clark, Inc., 944 Nandino Blvd., Lexington, KY 40511 | NADA 140-910 | 524.1580c |
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.