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

Federal Register, Volume 79 Issue 39 (Thursday, February 27, 2014)

Federal Register Volume 79, Number 39 (Thursday, February 27, 2014)

Rules and Regulations

Pages 10974-10976

From the Federal Register Online via the Government Printing 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, john.bartkowiak@fda.hhs.gov.

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:

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NADA/ANADA Ingredient new animal drugs

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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).

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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:

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NADA/ANADA Ingredient new animal drugs

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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).

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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

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NADA/ANADA Ingredient new animal drugs

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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).

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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:

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NADA Ingredient new animal drugs

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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).

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

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NADA Ingredient new animal drugs

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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).

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

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ANADA Ingredient new animal drugs

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200-355.................. 3-NITRO (roxarsone)/PENNCHLOR

(chlortetracycline)/BIO-COX (salinomycin).

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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

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