New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
Federal Register, Volume 82 Issue 36 (Friday, February 24, 2017)
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.
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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Approval of the following applications for new animal drugs administered in medicated feed is being voluntarily withdrawn at the sponsors' requests because these products are no longer manufactured or marketed:
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File No. Product name Sponsor
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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).
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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 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
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