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Home » 2014 Issues » 79 FR (02/27/2014) » 2014-02616. Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug Applications for Combination Drug Medicated Feeds Containing an Arsenical Drug

  2014-02616. Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug Applications for Combination Drug Medicated Feeds Containing an Arsenical Drug  

  • Start Preamble

    AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notification of withdrawal of approval.

    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.

    Start Further Info

    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, john.bartkowiak@fda.hhs.gov.

    End Further Info End Preamble Start Supplemental Information

    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/ANADAIngredient new animal drugs
    040-4353-NITRO (roxarsone)/DECCOX (decoquinate).
    041-178Roxarsone/AMPROL Plus (amprolium and ethopabate)/LINCOMIX (lincomycin).
    041-984Roxarsone/ROFENAID (sulfadimethoxine/ormetoprim).
    091-3263-NITRO (roxarsone)/DECCOX (decoquinate)/ALBAC (bacitracin zinc).
    092-522Roxarsone/COBAN (monensin)/LINCOMIX (lincomycin).
    095-546Roxarsone/ROBENZ (robenidine).
    102-4853-NITRO (roxarsone)/AVATEC (lasalocid).
    105-7583-NITRO (roxarsone)/AMPROL HI-E (amprolium and ethopabate)/BACIFERM (bacitracin zinc).
    112-6613-NITRO (roxarsone)/AVATEC (lasalocid)/LINCOMIX (lincomycin).
    112-6873-NITRO (roxarsone)/AVATEC (lasalocid)/FLAVOMYCIN (bambermycins).
    116-0823-NITRO (roxarsone)/AVATEC (lasalocid)/BMD (bacitracin MD).
    116-0883-NITRO (roxarsone)/COBAN (monensin)/BMD (bacitracin MD).
    123-1543-NITRO (roxarsone)/BACIFERM (bacitracin zinc)/COBAN (monensin).
    126-0523-NITRO (roxarsone)/AVATEC (lasalocid)/BACIFERM (bacitracin zinc).
    131-8943-NITRO (roxarsone)/AVATEC (lasalocid)/bacitracin MD.
    132-447Roxarsone/BIO-COX (salinomycin).
    Start Printed Page 10975
    134-1853-NITRO (roxarsone)/BIO-COX (salinomycin)/FLAVOMYCIN (bambermycins).
    135-3213-NITRO (roxarsone)/BIO-COX (salinomycin)/BMD (bacitracin MD).
    137-5363-NITRO (roxarsone)/BIO-COX/ALBAC (bacitracin zinc).
    138-7033-NITRO (roxarsone)/COBAN (monensin)/ALBAC (bacitracin zinc).
    139-1903-NITRO (roxarsone)/BIO-COX (salinomycin)/BACIFERM (bacitracin zinc).
    140-5813-NITRO (roxarsone)/BIO-COX (salinomycin)/LINCOMIX (lincomycin).
    140-8523-NITRO (roxarsone)/MONTEBAN/BMD (bacitracin MD).
    140-8673-NITRO (roxarsone)/BIO-COX (salinomycin)/AUREOMYCIN (chlortetracycline).
    141-1003-NITRO (roxarsone)/DECCOX (decoquinate)/BMD (bacitracin MD).
    141-1123-NITRO (roxarsone)/MAXIBAN (narasin and nicarbazin)/BMD (bacitracin MD).
    141-1213-NITRO (roxarsone)/BIO-COX (salinomycin)/BMD (bacitracin MD).
    141-1313-NITRO (roxarsone)/ZOAMIX (zoalene)/BMD (bacitracin MD).
    141-1353-NITRO (roxarsone)/BIO-COX (salinomycin).
    141-1383-NITRO (roxarsone)/COBAN (monensin)/BMD (bacitracin MD).
    141-1393-NITRO (roxarsone)/COBAN (monensin).
    141-1423-NITRO (roxarsone)/AMPROL (amprolium)/BMD (bacitracin MD).
    141-1553-NITRO (roxarsone)/ROBENZ (robenidine)/BMD (bacitracin MD).
    141-1573-NITRO (roxarsone)/STENOROL (halofuginone).
    141-2233-NITRO (roxarsone)/CLINACOX (diclazuril).
    141-2933-NITRO (roxarsone)/AVATEC (lasalocid).
    200-2063-NITRO (roxarsone)/ALBAC (bacitracin zinc)/DECCOX (decoquinate).
    200-2073-NITRO (roxarsone)/ALBAC (bacitracin zinc)/COYDEN 25 (clopidol).
    200-2083-NITRO (roxarsone)/ALBAC (bacitracin zinc)/AVATEC (lasalocid).
    200-2093-NITRO (roxarsone)/ALBAC (bacitracin zinc)/SACOX (salinomycin).
    200-2143-NITRO (roxarsone)/ALBAC (bacitracin zinc)/AMPROL HI-E (amprolium and ethopabate).
    200-2113-NITRO (roxarsone)/ALBAC (bacitracin zinc)/COBAN (monensin).
    200-2153-NITRO (roxarsone)/ALBAC (bacitracin zinc)/BIO-COX (salinomycin).
    200-2173-NITRO (roxarsone)/ALBAC (bacitracin zinc)/AMPROL HI-E (amprolium and ethopabate).
    200-2593-NITRO (roxarsone)/SACOX (salinomycin)/CHLORMAX (chlortetracycline).
    200-2603-NITRO (roxarsone)/BIO-COX (salinomycin)/CHLORMAX (chlortetracycline).
    038-879CARB-O-SEP (carbarsone)/ZOAMIX (zoalene).
    039-646CARB-O-GAIN (carbarsone)/BMD (bacitracin MD).
    136-484CARB-O-SEP (carbarsone)/BACIFERM (bacitracin zinc).
    200-203CARB-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/ANADAIngredient new animal drugs
    013-4613-NITRO (roxarsone)/AMPROL Plus (amprolium and ethopabate).
    040-2643-NITRO (roxarsone)/COYDEN 25 (clopidol).
    041-5413-NITRO (roxarsone)/COYDEN 25 (clopidol)/BMD (bacitracin MD).
    044-016Roxarsone/bacitracin Zinc/COYDEN 25 (clopidol).
    049-179Roxarsone/AMPROL HI-E (amprolium and ethopabate).
    049-180Roxarsone/AMPROL HI-E (amprolium and ethopabate)/BMD (bacitracin MD).
    095-5473-NITRO (roxarsone)/AMPROL HI-E (amprolium and ethopabate)/FLAVOMYCIN (bambermycins).
    095-5483-NITRO (roxarsone)/AMPROL (amprolium)/FLAVOMYCIN (bambermycins).
    095-5493-NITRO (roxarsone)/AMPROL (amprolium)/FLAVOMYCIN (bambermycins).
    098-3413-NITRO (roxarsone)/COBAN (monensin)/FLAVOMYCIN (bambermycins).
    101-6283-NITRO (roxarsone)/FLAVOMYCIN (bambermycins)/zoalene.
    140-5333-NITRO (roxarsone)/STENOROL (halofuginone)/BMD (bacitracin MD).
    140-8433-NITRO (roxarsone)/MONTEBAN (narasin)/FLAVOMYCIN (bambermycins).
    141-1903-NITRO (roxarsone)/CLINICOX (diclazuril)/BMD (bacitracin MD).
    200-0803-NITRO (roxarsone)/SACOX (salinomycin)/FLAVOMYCIN (bambermycins).
    200-0813-NITRO (roxarsone)/SACOX (salinomycin)/BMD (bacitracin MD).
    200-0863-NITRO (roxarsone)/SACOX (salinomycin)/ALBAC (bacitracin zinc).
    200-0903-NITRO (roxarsone)/SACOX (salinomycin)/LINCOMIX (lincomycin).
    200-0913-NITRO (roxarsone)/SACOX (salinomycin)/AUREOMYCIN (chlortetracycline).
    200-0943-NITRO (roxarsone)/SACOX (salinomycin)/STAFAC (virginiamycin).
    200-0973-NITRO (roxarsone)/SACOX (salinomycin).
    200-1433-NITRO (roxarsone)/SACOX (salinomycin)/BACIFERM (bacitracin zinc).
    118-507CARB-O-SEP (carbarsone)/AMPROL (amprolium).
    130-661CARB-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:Start Printed Page 10976
    NADA/ANADAIngredient new animal drugs
    107-997Roxarsone/NICARB (nicarbazin)/LINCOMIX (lincomycin).
    108-115Roxarsone/NICARB (nicarbazin).
    120-7243-NITRO (roxarsone)/STAFAC (virginiamycin)/COBAN (monensin).
    138-9533-NITRO (roxarsone)/STAFAC (virginiamycin)/BIO-COX (salinomycin).
    141-0583-NITRO (roxarsone)/AVIAX (semduramycin)/BMD (bacitracin MD).
    141-0663-NITRO (roxarsone)/AVIAX (semduramycin).
    141-226Roxarsone/AVIAX (semduramycin)/STAFAC (virginiamycin).
    200-1703-NITRO (roxarsone)/NICARMIX 25 (nicarbazin)/LINCOMIX (lincomycin).
    200-1723-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:
    NADAIngredient new animal drugs
    041-5003-NITRO (roxarsone)/COBAN (monensin).
    049-464Roxarsone/monensin/bacitracin.
    140-445Roxarsone/MONTEBAN (narasin).
    141-1133-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:
    NADAIngredient new animal drugs
    038-241PRO-GEN (arsanilic acid)/ERYTHRO (erythromycin)/zoalene.
    038-242PRO-GEN (arsanilic acid)/ERYTHRO (erythromycin)/amprolium and ethopabate.
    038-624PRO-GEN (arsanilic acid)/ERYTHRO (erythromycin).
    • Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144 has requested that FDA withdraw approval of the following ANADA:
    ANADAIngredient new animal drugs
    200-3553-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.

    Start Signature

    Dated: February 3, 2014.

    Bernadette Dunham,

    Director, Center for Veterinary Medicine.

    End Signature End Supplemental Information

    [FR Doc. 2014-02616 Filed 2-26-14; 8:45 am]

    BILLING CODE 4160-01-P

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Document Information

Effective Date:
3/10/2014
Published:
02/27/2014
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Notification of withdrawal of approval.
Document Number:
2014-02616
Dates:
Withdrawal of approval is effective March 10, 2014.
Pages:
10974-10976 (3 pages)
Docket Numbers:
Docket No. FDA-2014-N-0002
PDF File:
2014-02616.pdf
Supporting Documents:
» FREEDOM OF INFORMATION SUMMARY ANADA 200-512 TRIAMULOX tiamulin hydrogen fumarate, 12.3% Liquid Concentrate Swine re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
» FREEDOM OF INFORMATION SUMMARY NADA 034-267 GENTOCIN DURAFILM (Gentamicin Sulfate and Betamethasone) Sterile Ophthalmic Solution re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
» FREEDOM OF INFORMATION SUMMARY NADA 141-349 DRAXXIN 25 Injectable Solution Tulathromycin Injection Cattle (suckling calves, dairy calves, and veal calves) re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
» FREEDOM OF INFORMATION SUMMARY NADA 141-276 ZILMAX plus RUMENSIN plus TYLAN (zilpaterol hydrochloride 4.8%; monensin, USP; and tylosin phosphate) Type A Medicated Articles For Use in the Manufacture of Type B and C Medicated Feeds Cattle Fed in Confinemen
» FREEDOM OF INFORMATION SUMMARY NADA 141-258 ZILMAX Zilpaterol Hydrochloride 4.8% Type A medicated article to be used in the manufacture of Type B and C medicated feeds Cattle fed in confinement for slaughter re New Animal Drugs; Approval of New Animal Dru
» FREEDOM OF INFORMATION SUMMARY NADA 141-232 SIMPLICEF Cefpodoxime proxetil Chewable tablets Dogs re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
» FREEDOM OF INFORMATION SUMMARY NADA 141-068 BAYTRIL 100 Injectable Solution Enrofloxacin Swine re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
» FREEDOM OF INFORMATION SUMMARY NADA 141-034 GAINPRO bambermycins Type A Medicated Article to be used in the manufacture of Type C Medicated Feeds Pasture cattle (slaughter, stocker, and feeder cattle, and dairy and beef replacement heifers) re New Animal
» FREEDOM OF INFORMATION SUMMARY NADA 141-437 OSURNIA florfenicol, terbinafine, betamethasone acetate Otic gel Dogs re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
» FREEDOM OF INFORMATION SUMMARY ANADA 200-575 Carprofen Chewable Tablets Carprofen Dogs re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
CFR: (2)
21 CFR 556
21 CFR 558