Document ID: FDA-2012-N-0981-0001
Agency: fda
Document Type: Notice
Title: Withdrawals of Approvals of New Animal Drug Applications: Butorphanol; Doxapram; Triamcinolone; Tylosin
Posted Date: 2012-10-03T04:00Z

[Federal Register Volume 77, Number 192 (Wednesday, October 3, 2012)]
[Notices]
[Page 60442]
From the Federal Register Online via the Government Printing 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: 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.

   Table 1--NADA and ANADAs for Which Withdrawal of Approval Has Been
                                Requested
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       NADA/ANADA No.           Trade name (drug)         Applicant
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

    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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