Document ID: FDA-2018-N-0002-0001
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
Posted Date: 2018-09-28T04:00Z

[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)]
[Rules and Regulations]
[Page 48950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21147]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520, 522, 524, and 558

[Docket No. FDA-2018-N-0002]

New Animal Drugs; Withdrawal of Approval of New Animal Drug 
Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 12 new animal drug applications (NADAs) at the sponsor's request 
because these products are no longer manufactured or marketed.

DATES: Withdrawal of approval is effective October 9, 2018.

FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-402-5761, [email protected].

SUPPLEMENTARY INFORMATION: Virbac AH, Inc., 3200 Meacham Blvd., Ft. 
Worth, TX 76137, has requested that FDA withdraw approval of the NADAs 
listed in the following table because the products are no longer 
manufactured or marketed:

------------------------------------------------------------------------
       File No.                Product name            21 CFR section
------------------------------------------------------------------------
011-779...............  PURINA PIGEMIA 100         522.1182
                         (colloidal ferric oxide).
040-205...............  PURINA Horse Wormer        520.2380a
                         Medicated
                         (thiabendazole).
042-116...............  PURINA 6 DAY WORM-KILL     558.185
                         Feed Premix (coumaphos).
043-215...............  PURINA GRUB-KILL Pour-on   524.900
                         Cattle Insecticide
                         (famphur).
046-700...............  STATYL Medicated Premix    558.365
                         (nequinate).
091-260...............  PULVEX WORM CAPS           520.1804
                         (piperazine phosphate
                         monohydrate).
097-258...............  PURINA BAN-WORM for Pigs   558.485
                         (pyrantel tartrate).
102-942...............  PULVEX Multipurpose Worm   520.580
                         Caps (dichlorophene,
                         toluene).
113-748...............  PURINA PIGEMIA Oral (iron  520.1182
                         dextran complex).
135-941...............  CHECK-R-TON BM (pyrantel   558.485
                         tartrate).
136-116...............  PURINA WORM-A-RESTTM       520.905d
                         Litter Pack Premix
                         (fenbendazole).
140-869...............  PURINA SAF-T-BLOC BG       520.1840
                         Medicated Feed Block
                         (poloxalene, 6.6%).
------------------------------------------------------------------------

    Therefore, under authority delegated to the Commissioner of Food 
and Drugs, and in accordance with Sec.  514.116 Notice of withdrawal of 
approval of application (21 CFR 514.116), notice is given that approval 
of NADAs 011-779, 040-205, 042-116, 043-215, 046-700, 091-260, 097-258, 
102-942, 113-748, 135-941, 136-116, and 140-869, and all supplements 
and amendments thereto, is hereby withdrawn, effective October 9, 2018.
    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 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21147 Filed 9-27-18; 8:45 am]
 BILLING CODE 4164-01-P