77 FR 192 pg. 60442 - Withdrawal of Approval of New Animal Drug Applications; Butorphanol; Doxapram; Triamcinolone; Tylosin
Type: NOTICEVolume: 77Number: 192Page: 60442
Docket number: [Docket No. FDA-2012-N-0981]
FR document: [FR Doc. 2012-24330 Filed 10-2-12; 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-2012-N-0981]
Withdrawal of Approval of New Animal Drug Applications; Butorphanol; Doxapram; Triamcinolone; Tylosin
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
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.
DATES:
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: david.alterman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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.
| 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of NADA 100-556 and ANADAs 200-435, 200-446, and 200-459, and all supplements and amendments thereto, is hereby withdrawn, effective October 15, 2012.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.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-24330 Filed 10-2-12; 8:45 am]
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