79 FR 54 pgs. 15540-15541 - Withdrawal of Approval of New Animal Drug Applications; Chlortetracycline; Sulfathiazole; Penicillin
Type: RULEVolume: 79Number: 54Pages: 15540 - 15541
Pages: 15540, 15541Docket number: [Docket No. FDA-2014-N-0002]
FR document: [FR Doc. 2014-05883 Filed 3-19-14; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2014-N-0002]
Withdrawal of Approval of New Animal Drug Applications; Chlortetracycline; Sulfathiazole; Penicillin
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notification of withdrawal of approval.
SUMMARY:
The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) and two abbreviated new animal drug applications (ANADAs) for three-way, fixed-ratio combination drug Type A medicated articles containing chlortetracycline, sulfathiazole, and penicillin. This action is being taken at the sponsor's request because these products are no longer manufactured or marketed.
DATES:
Withdrawal of approval is effective March 31, 2014.
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.
SUPPLEMENTARY INFORMATION:
Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 has requested that FDA withdraw approval of the following NADA and two ANADAs because the products are no longer manufactured or marketed:
| NADA/ANADA | Proprietary name |
|---|---|
| 039-077 | CSP 250 (chlortetracycline, sulfathiazole, and penicillin) Type A medicated article. |
| 200-140 | AUREOZOL (chlortetracycline, sulfathiazole, and penicillin) Type A medicated article. |
| 200-167 | AUREOZOL 500 Granular (chlortetracycline, sulfathiazole, and penicillin) Type A medicated article. |
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The NADAs listed were 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 § 514.116 Notice of withdrawal of approval of application (21 CFR 514.116), notice is given that approval of NADA 039-077, ANADA 200-140, and ANADA 200-167, and all supplements and amendments thereto, is hereby withdrawn, effective March 31, 2014.
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: March 12, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-05883 Filed 3-19-14; 8:45 am]
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