| Page Range | 95025-95026 | |
| FR Document | 2016-31082 |
[Federal Register Volume 81, Number 248 (Tuesday, December 27, 2016)] [Rules and Regulations] [Pages 95025-95026] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-31082] ----------------------------------------------------------------------- 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 11 new animal drug applications (NADAs) and 4 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 being 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 December 30, 2016. 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, [email protected]. SUPPLEMENTARY INFORMATION: FDA is withdrawing approval of 11 NADAs and 4 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 Approval of the following applications for new animal drugs administered in medicated feed is being voluntarily withdrawn at the sponsors' requests because these products are no longer manufactured or marketed: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 ------------------------------------------------------------------------ 034-085........... LINCOMIX (lincomycin Zoetis Inc., 333 Portage hydrochloride St., Kalamazoo, MI monohydrate) Type A 49007. Medicated Article. 035-287........... OM-5 Premix Phibro Animal Health (oleandomycin) Type A Corp., GlenPointe Centre Medicated Article. East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666. 046-668........... Penicillin G Procaine 50% Phibro Animal Health Type A Medicated Article. Corp., GlenPointe Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666. 091-668........... CHLORMAX-SP 500 Zoetis Inc., 333 Portage (chlortetracycline, St., Kalamazoo, MI sulfamethazine, 49007. penicillin G procaine) Type A Medicated Article. 108-116........... LINCOMIX (lincomycin)/ Phibro Animal Health NICARB (nicarbazin). Corp., GlenPointe Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666. 133-334........... Virginiamycin Type A Zoetis Inc., 333 Portage Medicated Article. St., Kalamazoo, MI 49007. 139-473........... STAFAC (virginiamycin)/ Huvepharma EOOD, 5th STENEROL (halofuginone Floor, 3A Nikolay Haytov hydrobromide). Str., 1113 Sophia, Bulgaria. 140-340........... LINCOMIX (lincomycin)/ Huvepharma EOOD, 5th STENOROL (halofuginone Floor, 3A Nikolay Haytov hydrobromide). Str., 1113 Sophia, Bulgaria. 140-443........... HYGROMIX 1.6 (hygromycin Zoetis Inc., 333 Portage B) Type A Medicated St., Kalamazoo, MI Article. 49007. 140-947........... LINCOMIX (lincomycin)/ Elanco US, Inc., 2500 MAXIBAN (narasin and Innovation Way, nicarbazin). Greenfield, IN 46140. 141-090........... STAFAC (virginiamycin)/ Huvepharma EOOD, 5th CLINICOX (diclazuril). Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. 200-171........... LINCOMIX (lincomycin)/ Planalquimica Industrial NICARMIX (nicarbazin). Ltda., Rua das Magnolias nr. 2405, Jardim das Bandeiras, CEP 13053- 120, Campinas, Sao Paulo, Brazil. 200-569........... TYLAN (tylosin)/SACOX Huvepharma EOOD, 5th (salinomycin). Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. 200-570........... TYLOVET 100 (tylosin)/BIO- Huvepharma EOOD, 5th COX (salinomycin). Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. 200-580........... TYLOVET 100 (tylosin)/ Huvepharma EOOD, 5th SACOX (salinomycin). Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. ------------------------------------------------------------------------ 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 034-085, 035-287, 046-668, 091-668, 108-116, 133-334, 139-473, [[Page 95026]] 140-340, 140-443, 140-947, 141-090, 200-171, 200-569, 200-570, and 200- 580, and all supplements and amendments thereto, is hereby withdrawn, effective December 31, 2016. 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: December 20, 2016. Tracey H. Forfa, Deputy Director, Center for Veterinary Medicine. [FR Doc. 2016-31082 Filed 12-23-16; 8:45 am] BILLING CODE 4164-01-P
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Notification of withdrawal. | |
| Dates | Withdrawal of approval is effective December 30, 2016. | |
| Contact | Sujaya Dessai, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5761, [email protected] | |
| FR Citation | 81 FR 95025 |