# Withdrawal of Approval of New Animal Drug Applications; Ketamine; S-Methoprene; Nitazoxanide
**AGENCY:**
Food and Drug Administration, HHS.
**ACTION:**
Notice.
**SUMMARY:**
The Food and Drug Administration (FDA) is withdrawing approval of two new animal drug applications (NADAs) and an abbreviated new animal drug application (ANADA) listed in table 1 of this document. 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 these NADAs and ANADA.
**DATES:**
Withdrawal of approval is effective August 3, 2009.
**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 following sponsors have requested that FDA withdraw approval of the two NADAs and ANADA listed in table 1 of this document because the products are no longer manufactured or marketed:
| Sponsor | NADA/ANADA Number | 21 CFR Cite Affected |
| --- | --- | --- |
| Wellmark International, 1501 East Woodfield Rd., suite 200, West Schaumburg, IL 60173 | NADA 141-162 | 520.1390 (011536) |
| IDEXX Pharmaceuticals, Inc., 7009 Albert Pick Rd., Greensboro, NC 27409 | NADA 141-178 | 520.1498 (065274) |
| Abbott Laboratories, North Chicago, IL 60064 | ANADA 200-279 | 522.1222a (000074) |
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that approval of NADAs 141-162 and 141-178, and ANADA 200-279, and all supplements and amendments thereto, are hereby withdrawn, effective August 3, 2009.
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 14, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.