Rules and Regulations. Notification of withdrawal

Agency: Food and Drug Administration, HHS
Action: Notification of withdrawal
Citation: FR Doc. 2017-03595 · Docket No. FDA-2016-N-0002 · 21 CFR 558

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.

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 Approval of the following applications for new animal drugs administered in medicated feed is being voluntarily withdrawn at the sponsors' requests because these products are no longer manufactured or marketed: File No. Product name Sponsor 044-820 LINCOMIX (lincomycin)/AMPROL PLUS (amprolium and ethopabate) Zoetis Inc. 333 Portage St. Kalamazoo, MI 49007 (Zoetis Inc.). 044-972 LINCOMIX (lincomycin)/COYDEN (clopidol) Zoetis Inc. 047-261 LINCOMIX (lincomycin)/DECCOX (decoquinate) Zoetis Inc. 047-262 LINCOMIX (lincomycin)/DECCOX (decoquinate) Zoetis Inc. 048-954 LINCOMIX (lincomycin)/ZOAMIX (zoalene) Zoetis Inc. 091-513 STAFAC (virginiamycin) Type A Medicated Article Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666 (Phibro Animal Health Corp.). 092-482 LINCOMIX (lincomycin)/COBAN (monensin) Zoetis Inc. 093-106 LINCOMIX (lincomycin)/ROBENZ (robenidine) Zoetis Inc. 101-689 LINCOMIX (lincomycin)/AVATEC (lasalocid) Zoetis Inc. 122-481 STAFAC (virginiamycin)/COBAN (monensin) Phibro Animal Health Corp. 122-608 STAFAC (virginiamycin)/AVATEC (lasalocid) Phibro Animal Health Corp. 122-822 STAFAC (virginiamycin)/AMPROL PLUS (amprolium and ethopabate) Phibro Animal Health Corp. 137-537 LINCOMIX (lincomycin)/BIO-COX (salinomycin) Zoetis Inc. 138-792 TYLAN (tylosin)/RUMENSIN (monensin)/MGA (melengestrol acetate) Zoetis Inc. 138-828 STAFAC (virginiamycin)/BIO-COX (salinomycin) Phibro Animal Health Corp. 138-904 TYLAN (tylosin)/BOVATEC (lasalocid)/MGA (melengestrol acetate) Zoetis Inc. 141-110 STAFAC (virginiamycin)/COBAN (monensin) Phibro Animal Health Corp. 141-150 STAFAC (virginiamycin)/AVATEC (lasalocid) Phibro Animal Health Corp. 200-092 STAFAC (virginiamycin)/SACOX (salinomycin) Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria (Huvepharma EOOD). 200-093 LINCOMIX (lincomycin)/SACOX (salinomycin) Huvepharma EOOD. 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]