[Federal Register Volume 77, Number 192 (Wednesday, October 3, 2012)]
[Notices]
[Page 60442]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-24330]
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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.
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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: [email protected].
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.
Table 1--NADA and ANADAs for Which Withdrawal of Approval Has Been
Requested
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NADA/ANADA No. Trade name (drug) Applicant
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100-556..................... Vigorena Feeds Hy-Ty Springfield Milling
Premix (tylosin Corp., Vigorena
phosphate). Feeds, Springfield,
MN 56087.
200-435..................... RESPIRAM (doxapram Modern Veterinary
hydrochloride) Therapeutics, LLC,
Injection. 18001 Old Cutler
Rd., Suite 317,
Miami, FL 33157.
200-446..................... BUTORPHINE Modern Veterinary
(butorphanol Therapeutics, LLC,
tartrate) Injection. 18001 Old Cutler
Rd., Suite 317,
Miami, FL 33157.
200-459..................... VETAZINE Modern Veterinary
(triamcinolone) Therapeutics, LLC,
Cream. 18001 Old Cutler
Rd., Suite 317,
Miami, FL 33157.
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Therefore, under authority delegated to the Commissioner of Food
and Drugs and redelegated to the Center for Veterinary Medicine, and in
accordance with Sec. 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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