Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug Applications for Combination Drug Medicated Feeds Containing an Arsenical Drug, 10974-10976 [2014-02616]

Download as PDF 10974 Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Rules and Regulations and in its place add ‘‘048164, 054771, and 061623’’. § 529.1940 [Amended] 85. In paragraph (b) of § 529.1940, remove ‘‘000009’’ and in its place add ‘‘054771’’. ■ 86. Revise § 529.2464 to read as follows: ■ § 529.2464 Ticarcillin. (a) Specifications. Each vial contains ticarcillin disodium powder equivalent to 6 grams of ticarcillin for reconstitution with 25 milliliters of sterile water for injection or sterile physiological saline. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. Administer 6 grams daily by intrauterine infusion for 3 consecutive days during estrus. (2) Indications for use. For the treatment of endometritis caused by beta-hemolytic streptococci. (3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. ■ 87. Revise § 529.2503 to read as follows: § 529.2503 Tricaine methanesulfonate. (a) Specifications. The drug is ethylm-amino-benzoate methanesulfonate. (b) Sponsor. See Nos. 050378 and 051212 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. It is used as follows: (i) Fish. The drug is added to ambient water at a concentration of from 15 to 330 milligrams per liter depending upon the degree of anesthetization or sedation desired, the species and size of the fish, and the temperature and softness of the water. Preliminary tests of solutions must be made with small numbers of fish to determine the desired rates of sedation or anesthesia and the appropriate exposure times for the specific lots of fish under prevailing conditions. (ii) Amphibians and other aquatic coldblooded animals. The drug is added to ambient water in concentrations of from 1:1000 to 1:20,000 depending upon species and stage of development. (2) Indications for use. For the temporary immobilization of fish, amphibians, and other aquatic coldblooded animals (poikilotherms) as an aid in handling during manual spawning (fish stripping), weighing, measuring, marking, surgical operations, transport, photography, and research. (3) Limitations. Do not use within 21 days of harvesting fish for food. Use in fish intended for food should be restricted to Ictaluridae, Salmonidae, Esocidae, and Percidae, and water temperature exceeding 10 °C (50 °F). In other fish and in coldblooded animals, the drug should be limited to hatchery or laboratory use. Dated: January 27, 2014. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2014–01958 Filed 2–26–14; 8:45 am] BILLING CODE 4160–01–P 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. Notification of withdrawal of approval. ACTION: The Food and Drug Administration (FDA) is amending the SUMMARY: TKELLEY on DSK3SPTVN1PROD with RULES NADA/ANADA 040–435 041–178 041–984 091–326 092–522 095–546 102–485 105–758 112–661 112–687 116–082 116–088 123–154 126–052 131–894 132–447 ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ VerDate Mar<15>2010 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. Withdrawal of approval is effective March 10, 2014. DATES: 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. FOR FURTHER INFORMATION CONTACT: 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: SUPPLEMENTARY INFORMATION: Ingredient new animal drugs 3–NITRO (roxarsone)/DECCOX (decoquinate). Roxarsone/AMPROL Plus (amprolium and ethopabate)/LINCOMIX (lincomycin). Roxarsone/ROFENAID (sulfadimethoxine/ormetoprim). 3–NITRO (roxarsone)/DECCOX (decoquinate)/ALBAC (bacitracin zinc). Roxarsone/COBAN (monensin)/LINCOMIX (lincomycin). Roxarsone/ROBENZ (robenidine). 3–NITRO (roxarsone)/AVATEC (lasalocid). 3–NITRO (roxarsone)/AMPROL HI–E (amprolium and ethopabate)/BACIFERM (bacitracin zinc). 3–NITRO (roxarsone)/AVATEC (lasalocid)/LINCOMIX (lincomycin). 3–NITRO (roxarsone)/AVATEC (lasalocid)/FLAVOMYCIN (bambermycins). 3–NITRO (roxarsone)/AVATEC (lasalocid)/BMD (bacitracin MD). 3–NITRO (roxarsone)/COBAN (monensin)/BMD (bacitracin MD). 3–NITRO (roxarsone)/BACIFERM (bacitracin zinc)/COBAN (monensin). 3–NITRO (roxarsone)/AVATEC (lasalocid)/BACIFERM (bacitracin zinc). 3–NITRO (roxarsone)/AVATEC (lasalocid)/bacitracin MD. Roxarsone/BIO–COX (salinomycin). 16:18 Feb 26, 2014 Jkt 232001 PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 E:\FR\FM\27FER1.SGM 27FER1 Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Rules and Regulations NADA/ANADA 134–185 135–321 137–536 138–703 139–190 140–581 140–852 140–867 141–100 141–112 141–121 141–131 141–135 141–138 141–139 141–142 141–155 141–157 141–223 141–293 200–206 200–207 200–208 200–209 200–214 200–211 200–215 200–217 200–259 200–260 038–879 039–646 136–484 200–203 ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ Ingredient new animal drugs 3–NITRO (roxarsone)/BIO–COX (salinomycin)/FLAVOMYCIN (bambermycins). 3–NITRO (roxarsone)/BIO–COX (salinomycin)/BMD (bacitracin MD). 3–NITRO (roxarsone)/BIO–COX/ALBAC (bacitracin zinc). 3–NITRO (roxarsone)/COBAN (monensin)/ALBAC (bacitracin zinc). 3–NITRO (roxarsone)/BIO–COX (salinomycin)/BACIFERM (bacitracin zinc). 3–NITRO (roxarsone)/BIO–COX (salinomycin)/LINCOMIX (lincomycin). 3–NITRO (roxarsone)/MONTEBAN/BMD (bacitracin MD). 3–NITRO (roxarsone)/BIO–COX (salinomycin)/AUREOMYCIN (chlortetracycline). 3–NITRO (roxarsone)/DECCOX (decoquinate)/BMD (bacitracin MD). 3–NITRO (roxarsone)/MAXIBAN (narasin and nicarbazin)/BMD (bacitracin MD). 3–NITRO (roxarsone)/BIO–COX (salinomycin)/BMD (bacitracin MD). 3–NITRO (roxarsone)/ZOAMIX (zoalene)/BMD (bacitracin MD). 3–NITRO (roxarsone)/BIO–COX (salinomycin). 3–NITRO (roxarsone)/COBAN (monensin)/BMD (bacitracin MD). 3–NITRO (roxarsone)/COBAN (monensin). 3–NITRO (roxarsone)/AMPROL (amprolium)/BMD (bacitracin MD). 3–NITRO (roxarsone)/ROBENZ (robenidine)/BMD (bacitracin MD). 3–NITRO (roxarsone)/STENOROL (halofuginone). 3–NITRO (roxarsone)/CLINACOX (diclazuril). 3–NITRO (roxarsone)/AVATEC (lasalocid). 3–NITRO (roxarsone)/ALBAC (bacitracin zinc)/DECCOX (decoquinate). 3–NITRO (roxarsone)/ALBAC (bacitracin zinc)/COYDEN 25 (clopidol). 3–NITRO (roxarsone)/ALBAC (bacitracin zinc)/AVATEC (lasalocid). 3–NITRO (roxarsone)/ALBAC (bacitracin zinc)/SACOX (salinomycin). 3–NITRO (roxarsone)/ALBAC (bacitracin zinc)/AMPROL HI–E (amprolium and ethopabate). 3–NITRO (roxarsone)/ALBAC (bacitracin zinc)/COBAN (monensin). 3–NITRO (roxarsone)/ALBAC (bacitracin zinc)/BIO–COX (salinomycin). 3–NITRO (roxarsone)/ALBAC (bacitracin zinc)/AMPROL HI–E (amprolium and ethopabate). 3–NITRO (roxarsone)/SACOX (salinomycin)/CHLORMAX (chlortetracycline). 3–NITRO (roxarsone)/BIO–COX (salinomycin)/CHLORMAX (chlortetracycline). CARB–O–SEP (carbarsone)/ZOAMIX (zoalene). CARB–O–GAIN (carbarsone)/BMD (bacitracin MD). CARB–O–SEP (carbarsone)/BACIFERM (bacitracin zinc). 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: TKELLEY on DSK3SPTVN1PROD with RULES NADA/ANADA 013–461 040–264 041–541 044–016 049–179 049–180 095–547 095–548 095–549 098–341 101–628 140–533 140–843 141–190 200–080 200–081 200–086 200–090 200–091 200–094 200–097 200–143 118–507 130–661 ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ ............ Ingredient new animal drugs 3–NITRO (roxarsone)/AMPROL Plus (amprolium and ethopabate). 3–NITRO (roxarsone)/COYDEN 25 (clopidol). 3–NITRO (roxarsone)/COYDEN 25 (clopidol)/BMD (bacitracin MD). Roxarsone/bacitracin Zinc/COYDEN 25 (clopidol). Roxarsone/AMPROL HI–E (amprolium and ethopabate). Roxarsone/AMPROL HI–E (amprolium and ethopabate)/BMD (bacitracin MD). 3–NITRO (roxarsone)/AMPROL HI–E (amprolium and ethopabate)/FLAVOMYCIN (bambermycins). 3–NITRO (roxarsone)/AMPROL (amprolium)/FLAVOMYCIN (bambermycins). 3–NITRO (roxarsone)/AMPROL (amprolium)/FLAVOMYCIN (bambermycins). 3–NITRO (roxarsone)/COBAN (monensin)/FLAVOMYCIN (bambermycins). 3–NITRO (roxarsone)/FLAVOMYCIN (bambermycins)/zoalene. 3–NITRO (roxarsone)/STENOROL (halofuginone)/BMD (bacitracin MD). 3–NITRO (roxarsone)/MONTEBAN (narasin)/FLAVOMYCIN (bambermycins). 3–NITRO (roxarsone)/CLINICOX (diclazuril)/BMD (bacitracin MD). 3–NITRO (roxarsone)/SACOX (salinomycin)/FLAVOMYCIN (bambermycins). 3–NITRO (roxarsone)/SACOX (salinomycin)/BMD (bacitracin MD). 3–NITRO (roxarsone)/SACOX (salinomycin)/ALBAC (bacitracin zinc). 3–NITRO (roxarsone)/SACOX (salinomycin)/LINCOMIX (lincomycin). 3–NITRO (roxarsone)/SACOX (salinomycin)/AUREOMYCIN (chlortetracycline). 3–NITRO (roxarsone)/SACOX (salinomycin)/STAFAC (virginiamycin). 3–NITRO (roxarsone)/SACOX (salinomycin). 3–NITRO (roxarsone)/SACOX (salinomycin)/BACIFERM (bacitracin zinc). CARB–O–SEP (carbarsone)/AMPROL (amprolium). CARB–O–SEP (carbarsone)/FLAVOMYCIN (bambermycins). • Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 VerDate Mar<15>2010 10975 16:18 Feb 26, 2014 Jkt 232001 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666 has requested that FDA PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 withdraw approval of the following seven NADAs and two ANADAs: E:\FR\FM\27FER1.SGM 27FER1 10976 Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Rules and Regulations NADA/ANADA 107–997 108–115 120–724 138–953 141–058 141–066 141–226 200–170 200–172 ............ ............ ............ ............ ............ ............ ............ ............ ............ Ingredient new animal drugs Roxarsone/NICARB (nicarbazin)/LINCOMIX (lincomycin). Roxarsone/NICARB (nicarbazin). 3–NITRO (roxarsone)/STAFAC (virginiamycin)/COBAN (monensin). 3–NITRO (roxarsone)/STAFAC (virginiamycin)/BIO–COX (salinomycin). 3–NITRO (roxarsone)/AVIAX (semduramycin)/BMD (bacitracin MD). 3–NITRO (roxarsone)/AVIAX (semduramycin). Roxarsone/AVIAX (semduramycin)/STAFAC (virginiamycin). 3–NITRO (roxarsone)/NICARMIX 25 (nicarbazin)/LINCOMIX (lincomycin). 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 041–500 049–464 140–445 141–113 Ingredient new animal drugs ............ ............ ............ ............ 3–NITRO (roxarsone)/COBAN (monensin). Roxarsone/monensin/bacitracin. Roxarsone/MONTEBAN (narasin). 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 ............ 038–242 ............ 038–624 ............ PRO–GEN (arsanilic acid)/ERYTHRO (erythromycin)/zoalene. PRO–GEN (arsanilic acid)/ERYTHRO (erythromycin)/amprolium and ethopabate. 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). TKELLEY on DSK3SPTVN1PROD with RULES 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 VerDate Mar<15>2010 16:18 Feb 26, 2014 Jkt 232001 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. Final rule; technical amendments. ACTION: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of 69 new animal drug applications (NADAs) and 22 abbreviated new animal drug applications (ANADAs) for use of SUMMARY: PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 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. FDA is also amending the animal drug regulations to remove entries describing conditions of use for combination drug medicated feeds for which no NADA is approved. This action is being taken to improve the accuracy of the regulations. DATES: This rule 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 E:\FR\FM\27FER1.SGM 27FER1

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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:

------------------------------------------------------------------------
        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

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