[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:
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File No. Product name 21 CFR section
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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%).
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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]
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