Document ID: FDA-2016-N-0002-0033
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
Posted Date: 2016-12-27T05:00Z

[Federal Register Volume 81, Number 248 (Tuesday, December 27, 2016)]
[Rules and Regulations]
[Pages 95025-95026]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31082]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2016-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 11 new animal drug applications (NADAs) and 4 abbreviated new animal 
drug applications (ANADAs). These withdrawals of approval of NADAs and 
ANADAs for antimicrobial drugs of importance to human medicine that are 
administered to food-producing animals in medicated feed are being made 
because the products are no longer being manufactured or marketed. 
These actions are consistent with the FDA Center for Veterinary 
Medicine's initiative for the Judicious Use of Antimicrobials.

DATES: Withdrawal of approval is effective December 30, 2016.

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, sujaya.dessai@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is withdrawing approval of 11 NADAs and 
4 ANADAs. These applications 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 (http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf). Their 
withdrawal of approval is consistent with the FDA Center for Veterinary 
Medicine's initiative for the Judicious Use of Antimicrobials.
    Approval of the following applications for new animal drugs 
administered in medicated feed is being voluntarily withdrawn at the 
sponsors' requests because these products are no longer manufactured or 
marketed:

------------------------------------------------------------------------
     File No.              Product name                 Sponsor
------------------------------------------------------------------------
034-085...........  LINCOMIX (lincomycin       Zoetis Inc., 333 Portage
                     hydrochloride              St., Kalamazoo, MI
                     monohydrate) Type A        49007.
                     Medicated Article.
035-287...........  OM-5 Premix                Phibro Animal Health
                     (oleandomycin) Type A      Corp., GlenPointe Centre
                     Medicated Article.         East, 3d Floor, 300
                                                Frank W. Burr Blvd.,
                                                Suite 21, Teaneck, NJ
                                                07666.
046-668...........  Penicillin G Procaine 50%  Phibro Animal Health
                     Type A Medicated Article.  Corp., GlenPointe Centre
                                                East, 3d Floor, 300
                                                Frank W. Burr Blvd.,
                                                Suite 21, Teaneck, NJ
                                                07666.
091-668...........  CHLORMAX-SP 500            Zoetis Inc., 333 Portage
                     (chlortetracycline,        St., Kalamazoo, MI
                     sulfamethazine,            49007.
                     penicillin G procaine)
                     Type A Medicated Article.
108-116...........  LINCOMIX (lincomycin)/     Phibro Animal Health
                     NICARB (nicarbazin).       Corp., GlenPointe Centre
                                                East, 3d Floor, 300
                                                Frank W. Burr Blvd.,
                                                Suite 21, Teaneck, NJ
                                                07666.
133-334...........  Virginiamycin Type A       Zoetis Inc., 333 Portage
                     Medicated Article.         St., Kalamazoo, MI
                                                49007.
139-473...........  STAFAC (virginiamycin)/    Huvepharma EOOD, 5th
                     STENEROL (halofuginone     Floor, 3A Nikolay Haytov
                     hydrobromide).             Str., 1113 Sophia,
                                                Bulgaria.
140-340...........  LINCOMIX (lincomycin)/     Huvepharma EOOD, 5th
                     STENOROL (halofuginone     Floor, 3A Nikolay Haytov
                     hydrobromide).             Str., 1113 Sophia,
                                                Bulgaria.
140-443...........  HYGROMIX 1.6 (hygromycin   Zoetis Inc., 333 Portage
                     B) Type A Medicated        St., Kalamazoo, MI
                     Article.                   49007.
140-947...........  LINCOMIX (lincomycin)/     Elanco US, Inc., 2500
                     MAXIBAN (narasin and       Innovation Way,
                     nicarbazin).               Greenfield, IN 46140.
141-090...........  STAFAC (virginiamycin)/    Huvepharma EOOD, 5th
                     CLINICOX (diclazuril).     Floor, 3A Nikolay Haytov
                                                Str., 1113 Sophia,
                                                Bulgaria.
200-171...........  LINCOMIX (lincomycin)/     Planalquimica Industrial
                     NICARMIX (nicarbazin).     Ltda., Rua das Magnolias
                                                nr. 2405, Jardim das
                                                Bandeiras, CEP 13053-
                                                120, Campinas, Sao
                                                Paulo, Brazil.
200-569...........  TYLAN (tylosin)/SACOX      Huvepharma EOOD, 5th
                     (salinomycin).             Floor, 3A Nikolay Haytov
                                                Str., 1113 Sophia,
                                                Bulgaria.
200-570...........  TYLOVET 100 (tylosin)/BIO- Huvepharma EOOD, 5th
                     COX (salinomycin).         Floor, 3A Nikolay Haytov
                                                Str., 1113 Sophia,
                                                Bulgaria.
200-580...........  TYLOVET 100 (tylosin)/     Huvepharma EOOD, 5th
                     SACOX (salinomycin).       Floor, 3A Nikolay Haytov
                                                Str., 1113 Sophia,
                                                Bulgaria.
------------------------------------------------------------------------

    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 NADAs 
034-085, 035-287, 046-668, 091-668, 108-116, 133-334, 139-473,

[[Page 95026]]

140-340, 140-443, 140-947, 141-090, 200-171, 200-569, 200-570, and 200-
580, and all supplements and amendments thereto, is hereby withdrawn, 
effective December 31, 2016.
    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: December 20, 2016.
Tracey H. Forfa,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 2016-31082 Filed 12-23-16; 8:45 am]
 BILLING CODE 4164-01-P