The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) and three abbreviated new animal drug applications (ANADAs) at the sponsors' request because the products are no longer manufactured or marketed.
Withdrawal of approval is effective October 15, 2012.
FOR FURTHER INFORMATION CONTACT:
David Alterman, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-453-6843, email: firstname.lastname@example.org.
The following sponsors have requested that FDA withdraw approval of the NADA and ANADAs listed in table 1 of this document because the products are no longer manufactured or marketed.
Table 1—NADA and ANADAs for Which Withdrawal of Approval Has Been Requested
|NADA/ANADA No.||Trade name (drug)||Applicant|
|100-556||Vigorena Feeds Hy-Ty Premix (tylosin phosphate)||Springfield Milling Corp., Vigorena Feeds, Springfield, MN 56087.|
|200-435||RESPIRAM (doxapram hydrochloride) Injection||Modern Veterinary Therapeutics, LLC, 18001 Old Cutler Rd., Suite 317, Miami, FL 33157.|
|200-446||BUTORPHINE (butorphanol tartrate) Injection||Modern Veterinary Therapeutics, LLC, 18001 Old Cutler Rd., Suite 317, Miami, FL 33157.|
|200-459||VETAZINE (triamcinolone) Cream||Modern Veterinary Therapeutics, LLC, 18001 Old Cutler Rd., Suite 317, Miami, FL 33157.|
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of NADA 100-556 and ANADAs 200-435, 200-446, and 200-459, and all supplements and amendments thereto, is hereby withdrawn, effective October 15, 2012.
Elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect the voluntary withdrawal of approval of these applications.
Dated: September 27, 2012.
Director, Center for Veterinary Medicine.
[FR Doc. 2012-24330 Filed 10-2-12; 8:45 am]
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