Document ID: FDA-2016-N-0002-0037
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
Posted Date: 2017-02-24T05:00Z

[Federal Register Volume 82, Number 36 (Friday, February 24, 2017)]
[Rules and Regulations]
[Pages 11509-11510]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03595]

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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 18 new animal drug applications (NADAs) and 2 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 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 February 24, 2017.

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 18 NADAs and 
2 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administered in medicated feed is being voluntarily withdrawn at the 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
------------------------------------------------------------------------
044-820.....................  LINCOMIX              Zoetis Inc.
                               (lincomycin)/AMPROL  333 Portage St.
                               PLUS (amprolium and  Kalamazoo, MI 49007
                               ethopabate).          (Zoetis Inc.).

[[Page 11510]]

 
044-972.....................  LINCOMIX              Zoetis Inc.
                               (lincomycin)/COYDEN
                               (clopidol).
047-261.....................  LINCOMIX              Zoetis Inc.
                               (lincomycin)/DECCOX
                               (decoquinate).
047-262.....................  LINCOMIX              Zoetis Inc.
                               (lincomycin)/DECCOX
                               (decoquinate).
048-954.....................  LINCOMIX              Zoetis Inc.
                               (lincomycin)/ZOAMIX
                               (zoalene).
091-513.....................  STAFAC                Phibro Animal Health
                               (virginiamycin)       Corp., GlenPointe
                               Type A Medicated      Centre East, 3d
                               Article.              floor, 300 Frank W.
                                                     Burr Blvd., Suite
                                                     21, Teaneck, NJ
                                                     07666 (Phibro
                                                     Animal Health
                                                     Corp.).
092-482.....................  LINCOMIX              Zoetis Inc.
                               (lincomycin)/COBAN
                               (monensin).
093-106.....................  LINCOMIX              Zoetis Inc.
                               (lincomycin)/ROBENZ
                               (robenidine).
101-689.....................  LINCOMIX              Zoetis Inc.
                               (lincomycin)/AVATEC
                               (lasalocid).
122-481.....................  STAFAC                Phibro Animal Health
                               (virginiamycin)/      Corp.
                               COBAN (monensin).
122-608.....................  STAFAC                Phibro Animal Health
                               (virginiamycin)/      Corp.
                               AVATEC (lasalocid).
122-822.....................  STAFAC                Phibro Animal Health
                               (virginiamycin)/      Corp.
                               AMPROL PLUS
                               (amprolium and
                               ethopabate).
137-537.....................  LINCOMIX              Zoetis Inc.
                               (lincomycin)/BIO-
                               COX (salinomycin).
138-792.....................  TYLAN (tylosin)/      Zoetis Inc.
                               RUMENSIN (monensin)/
                               MGA (melengestrol
                               acetate).
138-828.....................  STAFAC                Phibro Animal Health
                               (virginiamycin)/BIO-  Corp.
                               COX (salinomycin).
138-904.....................  TYLAN (tylosin)/      Zoetis Inc.
                               BOVATEC (lasalocid)/
                               MGA (melengestrol
                               acetate).
141-110.....................  STAFAC                Phibro Animal Health
                               (virginiamycin)/      Corp.
                               COBAN (monensin).
141-150.....................  STAFAC                Phibro Animal Health
                               (virginiamycin)/      Corp.
                               AVATEC (lasalocid).
200-092.....................  STAFAC                Huvepharma EOOD, 5th
                               (virginiamycin)/      Floor, 3A Nikolay
                               SACOX (salinomycin).  Haytov Str., 1113
                                                     Sophia, Bulgaria
                                                     (Huvepharma EOOD).
200-093.....................  LINCOMIX              Huvepharma EOOD.
                               (lincomycin)/SACOX
                               (salinomycin).
------------------------------------------------------------------------

    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 
044-820, 044-972, 047-261, 047-262, 048-954, 091-513, 092-482, 093-106, 
101-689, 122-481, 122-608, 122-822, 137-537, 138-792, 138-828, 138-904, 
141-110, 141-150, 200-092, and 200-093, and all supplements and 
amendments thereto, is hereby withdrawn, effective February 24, 2017.
    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: February 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-03595 Filed 2-23-17; 8:45 am]
 BILLING CODE 4164-01-P