74 FR 139 pg. 36241 - Withdrawal of Approval of New Animal Drug Applications; Ketamine; S-Methoprene; Nitazoxanide
Type: NOTICEVolume: 74Number: 139Page: 36241
Docket number: [Docket No. FDA-2009-N-0302]
FR document: [FR Doc. E9-17408 Filed 7-21-09; 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. FDA-2009-N-0302]
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: john.bartkowiak@fda.hhs.gov .
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 Product (Drug) | 21 CFR Cite Affected (Sponsor Drug Labeler Code) |
|---|---|---|
| Wellmark International, 1501 East Woodfield Rd., suite 200, West Schaumburg, IL 60173 | NADA 141-162 Zodiac Fleatrol Flea Caps (S-methoprene) | 520.1390 (011536) |
| IDEXX Pharmaceuticals, Inc., 7009 Albert Pick Rd., Greensboro, NC 27409 | NADA 141-178 NAVIGATOR Paste (nitazoxanide) | 520.1498 (065274) |
| Abbott Laboratories, North Chicago, IL 60064 | ANADA 200-279 KETAFLO Injection (ketamine HCl, USP) | 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that approval of NADAs 141-162 and 141-178, and ANADA 200-279, and all supplements and amendments thereto, are hereby withdrawn, effective August 3, 2009.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.
[FR Doc. E9-17408 Filed 7-21-09; 8:45 am]
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