New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications, 11509-11510 [2017-03595]

Download as PDF Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Rules and Regulations § 558.68 16. In § 558.68, revise paragraph (e)(1)(ii) to read as follows: ■ * Avilamycin. * * * (e) * * * (1) * * * * Avilamycin in grams/ton Combination in grams/ton Indications for use * (ii) 13.6 to 40.9 ........ * Monensin 90 to 110; as provided by No. 058198 in § 510.600(c) of this chapter. * * Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens in broiler chickens; and as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima. Limitations [Docket No. FDA–2016–N–0002] New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application Dated: February 21, 2017. Leslie Kux, Associate Commissioner for Policy. * * * * Dated: February 21, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–03677 Filed 2–23–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 524 AGENCY: Food and Drug Administration, ACTION: Notification of withdrawal. The Food and Drug Administration (FDA) is withdrawing approval of an abbreviated new animal drug application (ANADA) at the sponsor’s request because the product is no longer manufactured or marketed. DATES: Withdrawal of approval is effective March 6, 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: Putney, Inc., One Monument Square, Suite 400, Portland, ME 04101 has requested that FDA withdraw approval of ANADA 200–524 for Mupirocin Ointment 2% because the product is no longer manufactured or marketed. SUMMARY: pmangrum on DSK3GDR082PROD with RULES [FR Doc. 2017–03678 Filed 2–23–17; 8:45 am] BILLING CODE 4164–01–P HHS. 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. 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 SUMMARY: File No. LINCOMIX (lincomycin)/AMPROL PLUS (amprolium and ethopabate). 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. Withdrawal of approval is effective February 24, 2017. DATES: 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: Product name 044–820 ...................................... VerDate Sep<11>2014 14:13 Feb 23, 2017 Jkt 241001 PO 00000 Frm 00009 Fmt 4700 Sponsor Sfmt 4700 Sponsor * * * Feed as the sole ration for 21 consecu058198 tive days. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 10 days of age. See § 558.355(d) of this chapter for additional required labeling. Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, and in accordance with § 514.116 Notice of withdrawal of approval of application (21 CFR 514.116), notice is given that approval of ANADA 200–524, and all supplements and amendments thereto, is hereby withdrawn, effective March 6, 2017. Elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect the voluntary withdrawal of approval of this application. * 11509 Zoetis Inc. 333 Portage St. Kalamazoo, MI 49007 (Zoetis Inc.). E:\FR\FM\24FER1.SGM 24FER1 11510 Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Rules and Regulations File No. Product name Sponsor Zoetis Inc. Zoetis Inc. Zoetis Inc. Zoetis Inc. Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666 (Phibro Animal Health Corp.). Zoetis Inc. Zoetis Inc. Zoetis Inc. Phibro Animal Health Corp. Phibro Animal Health Corp. Phibro Animal Health Corp. 044–972 047–261 047–262 048–954 091–513 ...................................... ...................................... ...................................... ...................................... ...................................... LINCOMIX (lincomycin)/COYDEN (clopidol) ............... LINCOMIX (lincomycin)/DECCOX (decoquinate) ....... LINCOMIX (lincomycin)/DECCOX (decoquinate) ....... LINCOMIX (lincomycin)/ZOAMIX (zoalene) ................ STAFAC (virginiamycin) Type A Medicated Article ..... 092–482 093–106 101–689 122–481 122–608 122–822 ...................................... ...................................... ...................................... ...................................... ...................................... ...................................... 141–110 ...................................... 141–150 ...................................... 200–092 ...................................... LINCOMIX (lincomycin)/COBAN (monensin) .............. LINCOMIX (lincomycin)/ROBENZ (robenidine) ........... LINCOMIX (lincomycin)/AVATEC (lasalocid) .............. STAFAC (virginiamycin)/COBAN (monensin) ............. STAFAC (virginiamycin)/AVATEC (lasalocid) ............. STAFAC (virginiamycin)/AMPROL PLUS (amprolium and ethopabate). LINCOMIX (lincomycin)/BIO–COX (salinomycin) ........ TYLAN (tylosin)/RUMENSIN (monensin)/MGA (melengestrol acetate). STAFAC (virginiamycin)/BIO–COX (salinomycin) ....... TYLAN (tylosin)/BOVATEC (lasalocid)/MGA (melengestrol acetate). STAFAC (virginiamycin)/COBAN (monensin) ............. STAFAC (virginiamycin)/AVATEC (lasalocid) ............. STAFAC (virginiamycin)/SACOX (salinomycin) .......... 200–093 ...................................... LINCOMIX (lincomycin)/SACOX (salinomycin) ........... 137–537 ...................................... 138–792 ...................................... 138–828 ...................................... 138–904 ...................................... Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, and in accordance with § 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] pmangrum on DSK3GDR082PROD with RULES BILLING CODE 4164–01–P VerDate Sep<11>2014 14:13 Feb 23, 2017 Jkt 241001 Zoetis Inc. Zoetis Inc. Phibro Animal Health Corp. Zoetis Inc. Phibro Animal Health Corp. Phibro Animal Health Corp. Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria (Huvepharma EOOD). Huvepharma EOOD. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 [Docket No. FDA–2016–N–0002] New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications AGENCY: Food and Drug Administration, HHS. Final rule; technical amendment. ACTION: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of eight supplemental new animal drug applications (NADAs). The effect of these supplemental applications will be to change the marketing status from over-the-counter (OTC) use to use by veterinary feed directive (VFD) for these antimicrobial drugs of importance to human medicine, administered to foodproducing animals in medicated feed. Where applicable, FDA is also withdrawing approval of those parts of the NADAs that pertain to use of these antimicrobial drugs for production indications. These actions are being taken at the sponsors’ requests because these particular medicated feeds will no longer be manufactured or marketed. These applications were submitted in voluntary compliance with the goals of FDA Center for Veterinary Medicine’s SUMMARY: PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 (CVM’s) Judicious Use Initiative. In addition, the animal drug regulations are being amended to reflect the voluntary withdrawal of approval of certain entire NADAs and abbreviated new animal drug applications (ANADAs) that were affected by this initiative. DATES: This rule is effective February 24, 2017. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV–6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–5689, george.haibel@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Supplemental Approval of Revised Labeling and Withdrawal of Approval of Portions of NADAs Pertaining to Production Indications FDA is amending the animal drug regulations to reflect approval of eight supplemental NADAs for revised labeling reflecting a change in marketing status from OTC use to use by VFD for antimicrobial drugs of importance to human medicine administered to foodproducing animals in medicated feed. Where applicable, FDA is also withdrawing approval of those parts of the NADAs that pertain to use of these antimicrobial drugs for production indications. These actions are being taken at the sponsors’ requests because these particular medicated feeds will no longer be manufactured or marketed. These applications were identified as being affected by guidance for industry (GFI) #213, ‘‘New Animal Drugs and E:\FR\FM\24FER1.SGM 24FER1

Agencies

[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.

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

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