[Federal Register Volume 79, Number 39 (Thursday, February 27, 2014)]
[Rules and Regulations]
[Pages 10974-10976]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-02616]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 556 and 558

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


Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug 
Applications for Combination Drug Medicated Feeds Containing an 
Arsenical Drug

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of withdrawal of approval.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect the withdrawal approval of 69 new animal 
drug applications (NADAs) and 22 abbreviated new animal drug 
applications (ANADAs) for use of arsanilic acid, carbarsone, or 
roxarsone Type A medicated articles to manufacture combination drug 
Type B and Type C medicated feeds. This action is being taken at the 
sponsor's request because the products are no longer manufactured or 
marketed.

DATES: Withdrawal of approval is effective March 10, 2014.

FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-276-9079, [email protected].

SUPPLEMENTARY INFORMATION: Recently, the Agency provided notice of the 
withdrawal of approval of NADAs for Type A medicated articles 
containing arsanilic acid, carbarsone, and roxarsone and revoked 
applicable regulations for their conditions of use to manufacture 
single-ingredient medicated feeds in 21 CFR part 558 New Animal Drugs 
For Use in Animal Feeds (78 FR 70062, November 22, 2013; 78 FR 69992, 
November 22, 2013; 78 FR 70566, November 26, 2013; 78 FR 70496, 
November 26, 2013).
    Subsequently, the following six sponsors of NADAs and ANADAs 
permitting use of arsanilic acid, carbarsone, or roxarsone Type A 
medicated articles to manufacture combination drug Type B and Type C 
medicated feeds requested that FDA withdraw approval of their 
applications because these combination medicated feeds are no longer 
manufactured or marketed.
     Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 has 
requested that FDA withdraw approval of the following 39 NADAs and 11 
ANADAs:

------------------------------------------------------------------------
        NADA/ANADA                  Ingredient new animal drugs
------------------------------------------------------------------------
040-435..................  3-NITRO (roxarsone)/DECCOX (decoquinate).
041-178..................  Roxarsone/AMPROL Plus (amprolium and
                            ethopabate)/LINCOMIX (lincomycin).
041-984..................  Roxarsone/ROFENAID (sulfadimethoxine/
                            ormetoprim).
091-326..................  3-NITRO (roxarsone)/DECCOX (decoquinate)/
                            ALBAC (bacitracin zinc).
092-522..................  Roxarsone/COBAN (monensin)/LINCOMIX
                            (lincomycin).
095-546..................  Roxarsone/ROBENZ (robenidine).
102-485..................  3-NITRO (roxarsone)/AVATEC (lasalocid).
105-758..................  3-NITRO (roxarsone)/AMPROL HI-E (amprolium
                            and ethopabate)/BACIFERM (bacitracin zinc).
112-661..................  3-NITRO (roxarsone)/AVATEC (lasalocid)/
                            LINCOMIX (lincomycin).
112-687..................  3-NITRO (roxarsone)/AVATEC (lasalocid)/
                            FLAVOMYCIN (bambermycins).
116-082..................  3-NITRO (roxarsone)/AVATEC (lasalocid)/BMD
                            (bacitracin MD).
116-088..................  3-NITRO (roxarsone)/COBAN (monensin)/BMD
                            (bacitracin MD).
123-154..................  3-NITRO (roxarsone)/BACIFERM (bacitracin
                            zinc)/COBAN (monensin).
126-052..................  3-NITRO (roxarsone)/AVATEC (lasalocid)/
                            BACIFERM (bacitracin zinc).
131-894..................  3-NITRO (roxarsone)/AVATEC (lasalocid)/
                            bacitracin MD.
132-447..................  Roxarsone/BIO-COX (salinomycin).

[[Page 10975]]

 
134-185..................  3-NITRO (roxarsone)/BIO-COX (salinomycin)/
                            FLAVOMYCIN (bambermycins).
135-321..................  3-NITRO (roxarsone)/BIO-COX (salinomycin)/BMD
                            (bacitracin MD).
137-536..................  3-NITRO (roxarsone)/BIO-COX/ALBAC (bacitracin
                            zinc).
138-703..................  3-NITRO (roxarsone)/COBAN (monensin)/ALBAC
                            (bacitracin zinc).
139-190..................  3-NITRO (roxarsone)/BIO-COX (salinomycin)/
                            BACIFERM (bacitracin zinc).
140-581..................  3-NITRO (roxarsone)/BIO-COX (salinomycin)/
                            LINCOMIX (lincomycin).
140-852..................  3-NITRO (roxarsone)/MONTEBAN/BMD (bacitracin
                            MD).
140-867..................  3-NITRO (roxarsone)/BIO-COX (salinomycin)/
                            AUREOMYCIN (chlortetracycline).
141-100..................  3-NITRO (roxarsone)/DECCOX (decoquinate)/BMD
                            (bacitracin MD).
141-112..................  3-NITRO (roxarsone)/MAXIBAN (narasin and
                            nicarbazin)/BMD (bacitracin MD).
141-121..................  3-NITRO (roxarsone)/BIO-COX (salinomycin)/BMD
                            (bacitracin MD).
141-131..................  3-NITRO (roxarsone)/ZOAMIX (zoalene)/BMD
                            (bacitracin MD).
141-135..................  3-NITRO (roxarsone)/BIO-COX (salinomycin).
141-138..................  3-NITRO (roxarsone)/COBAN (monensin)/BMD
                            (bacitracin MD).
141-139..................  3-NITRO (roxarsone)/COBAN (monensin).
141-142..................  3-NITRO (roxarsone)/AMPROL (amprolium)/BMD
                            (bacitracin MD).
141-155..................  3-NITRO (roxarsone)/ROBENZ (robenidine)/BMD
                            (bacitracin MD).
141-157..................  3-NITRO (roxarsone)/STENOROL (halofuginone).
141-223..................  3-NITRO (roxarsone)/CLINACOX (diclazuril).
141-293..................  3-NITRO (roxarsone)/AVATEC (lasalocid).
200-206..................  3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/
                            DECCOX (decoquinate).
200-207..................  3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/
                            COYDEN 25 (clopidol).
200-208..................  3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/
                            AVATEC (lasalocid).
200-209..................  3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/
                            SACOX (salinomycin).
200-214..................  3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/
                            AMPROL HI-E (amprolium and ethopabate).
200-211..................  3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/
                            COBAN (monensin).
200-215..................  3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/
                            BIO-COX (salinomycin).
200-217..................  3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/
                            AMPROL HI-E (amprolium and ethopabate).
200-259..................  3-NITRO (roxarsone)/SACOX (salinomycin)/
                            CHLORMAX (chlortetracycline).
200-260..................  3-NITRO (roxarsone)/BIO-COX (salinomycin)/
                            CHLORMAX (chlortetracycline).
038-879..................  CARB-O-SEP (carbarsone)/ZOAMIX (zoalene).
039-646..................  CARB-O-GAIN (carbarsone)/BMD (bacitracin MD).
136-484..................  CARB-O-SEP (carbarsone)/BACIFERM (bacitracin
                            zinc).
200-203..................  CARB-O-SEP (carbarsone)/ALBAC (bacitracin
                            zinc).
------------------------------------------------------------------------

     Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 
Sofia, Bulgaria has requested that FDA withdraw approval of the 
following 16 NADAs and 8 ANADAs:

------------------------------------------------------------------------
        NADA/ANADA                  Ingredient new animal drugs
------------------------------------------------------------------------
013-461..................  3-NITRO (roxarsone)/AMPROL Plus (amprolium
                            and ethopabate).
040-264..................  3-NITRO (roxarsone)/COYDEN 25 (clopidol).
041-541..................  3-NITRO (roxarsone)/COYDEN 25 (clopidol)/BMD
                            (bacitracin MD).
044-016..................  Roxarsone/bacitracin Zinc/COYDEN 25
                            (clopidol).
049-179..................  Roxarsone/AMPROL HI-E (amprolium and
                            ethopabate).
049-180..................  Roxarsone/AMPROL HI-E (amprolium and
                            ethopabate)/BMD (bacitracin MD).
095-547..................  3-NITRO (roxarsone)/AMPROL HI-E (amprolium
                            and ethopabate)/FLAVOMYCIN (bambermycins).
095-548..................  3-NITRO (roxarsone)/AMPROL (amprolium)/
                            FLAVOMYCIN (bambermycins).
095-549..................  3-NITRO (roxarsone)/AMPROL (amprolium)/
                            FLAVOMYCIN (bambermycins).
098-341..................  3-NITRO (roxarsone)/COBAN (monensin)/
                            FLAVOMYCIN (bambermycins).
101-628..................  3-NITRO (roxarsone)/FLAVOMYCIN (bambermycins)/
                            zoalene.
140-533..................  3-NITRO (roxarsone)/STENOROL (halofuginone)/
                            BMD (bacitracin MD).
140-843..................  3-NITRO (roxarsone)/MONTEBAN (narasin)/
                            FLAVOMYCIN (bambermycins).
141-190..................  3-NITRO (roxarsone)/CLINICOX (diclazuril)/BMD
                            (bacitracin MD).
200-080..................  3-NITRO (roxarsone)/SACOX (salinomycin)/
                            FLAVOMYCIN (bambermycins).
200-081..................  3-NITRO (roxarsone)/SACOX (salinomycin)/BMD
                            (bacitracin MD).
200-086..................  3-NITRO (roxarsone)/SACOX (salinomycin)/ALBAC
                            (bacitracin zinc).
200-090..................  3-NITRO (roxarsone)/SACOX (salinomycin)/
                            LINCOMIX (lincomycin).
200-091..................  3-NITRO (roxarsone)/SACOX (salinomycin)/
                            AUREOMYCIN (chlortetracycline).
200-094..................  3-NITRO (roxarsone)/SACOX (salinomycin)/
                            STAFAC (virginiamycin).
200-097..................  3-NITRO (roxarsone)/SACOX (salinomycin).
200-143..................  3-NITRO (roxarsone)/SACOX (salinomycin)/
                            BACIFERM (bacitracin zinc).
118-507..................  CARB-O-SEP (carbarsone)/AMPROL (amprolium).
130-661..................  CARB-O-SEP (carbarsone)/FLAVOMYCIN
                            (bambermycins).
------------------------------------------------------------------------

     Phibro Animal Health Corp., GlenPointe Centre East, 3d 
floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666 has 
requested that FDA withdraw approval of the following seven NADAs and 
two ANADAs:

[[Page 10976]]



------------------------------------------------------------------------
        NADA/ANADA                  Ingredient new animal drugs
------------------------------------------------------------------------
107-997..................  Roxarsone/NICARB (nicarbazin)/LINCOMIX
                            (lincomycin).
108-115..................  Roxarsone/NICARB (nicarbazin).
120-724..................  3-NITRO (roxarsone)/STAFAC (virginiamycin)/
                            COBAN (monensin).
138-953..................  3-NITRO (roxarsone)/STAFAC (virginiamycin)/
                            BIO-COX (salinomycin).
141-058..................  3-NITRO (roxarsone)/AVIAX (semduramycin)/BMD
                            (bacitracin MD).
141-066..................  3-NITRO (roxarsone)/AVIAX (semduramycin).
141-226..................  Roxarsone/AVIAX (semduramycin)/STAFAC
                            (virginiamycin).
200-170..................  3-NITRO (roxarsone)/NICARMIX 25 (nicarbazin)/
                            LINCOMIX (lincomycin).
200-172..................  3-NITRO (roxarsone)/NICARMIX 25 (nicarbazin).
------------------------------------------------------------------------

     Elanco Animal Health, A Division of Eli Lilly & Co., Lilly 
Corporate Center, Indianapolis, IN 46285 has requested that FDA 
withdraw approval of the following four NADAs:

------------------------------------------------------------------------
           NADA                     Ingredient new animal drugs
------------------------------------------------------------------------
041-500..................  3-NITRO (roxarsone)/COBAN (monensin).
049-464..................  Roxarsone/monensin/bacitracin.
140-445..................  Roxarsone/MONTEBAN (narasin).
141-113..................  3-NITRO (roxarsone)/MAXIBAN (narasin and
                            nicarbazin).
------------------------------------------------------------------------

     Cross Vetpharm Group Ltd., Broomhill Road, Tallaght, 
Dublin 24, Ireland, has requested that FDA withdraw approval of the 
following three NADAs:

------------------------------------------------------------------------
           NADA                     Ingredient new animal drugs
------------------------------------------------------------------------
038-241..................  PRO-GEN (arsanilic acid)/ERYTHRO
                            (erythromycin)/zoalene.
038-242..................  PRO-GEN (arsanilic acid)/ERYTHRO
                            (erythromycin)/amprolium and ethopabate.
038-624..................  PRO-GEN (arsanilic acid)/ERYTHRO
                            (erythromycin).
------------------------------------------------------------------------

     Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144 
has requested that FDA withdraw approval of the following ANADA:

------------------------------------------------------------------------
          ANADA                     Ingredient new animal drugs
------------------------------------------------------------------------
200-355..................  3-NITRO (roxarsone)/PENNCHLOR
                            (chlortetracycline)/BIO-COX (salinomycin).
------------------------------------------------------------------------

    Therefore, under authority delegated to the Commissioner of Food 
and Drugs and redelegated to the Center for Veterinary Medicine, and in 
accordance with 21 CFR 514.116 Notice of withdrawal of approval of 
application, notice is given that approval of the NADAs and ANADAs 
listed in this document, and all supplements and amendments thereto, is 
hereby withdrawn, effective March 10, 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: February 3, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-02616 Filed 2-26-14; 8:45 am]
BILLING CODE 4160-01-P