Document ID: FDA-2014-N-0002-0065
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs; Withdrawal of Approval of New 
Animal Drug Application; Oxytetracycline
Posted Date: 2014-12-15T05:00Z

[Federal Register Volume 79, Number 240 (Monday, December 15, 2014)]
[Unknown Section]
[Page 74021]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-29248]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2014-N-0002]

Oral Dosage Form New Animal Drugs; Withdrawal of Approval of New 
Animal Drug Application; Oxytetracycline

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of withdrawal of approval.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of an abbreviated new animal drug application (ANADA) for an 
oxytetracycline soluble powder used to make medicated drinking water 
for livestock and poultry. This action is being taken at the sponsor's 
request because this product is no longer manufactured or marketed.

DATES: Withdrawal of approval is effective December 26, 2014.

FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-276-9075, sujaya.dessai@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: V[eacute]toquinol N.-A., Inc., 2000 chemin 
Georges, Lavaltrie (PQ), Canada, J5T 3S5 has requested that FDA 
withdraw approval of ANADA 200-305 for Oxytetracycline Hydrochloride 
Soluble Powder because the product is no longer manufactured or 
marketed. Note this ANADA was identified as being affected by guidance 
for industry (GFI) #213, ``New Animal Drugs and New Animal Drug 
Combination Products Administered in or on Medicated Feed or Drinking 
Water of Food-Producing Animals: Recommendations for Drug Sponsors for 
Voluntarily Aligning Product Use Conditions with GFI #209'', December 
2013.
    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 ANADA 
200-305, and all supplements and amendments thereto, is hereby 
withdrawn, effective December 26, 2014.
    Elsewhere in this issue of the Federal Register, FDA is amending 
the animal drug regulations to reflect the voluntary withdrawal of 
approval of this application.

    Dated: December 9, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-29248 Filed 12-12-14; 8:45 am]
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