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Approval of the following applications for new animal drugs administered in medicated feed is being voluntarily withdrawn at the sponsors' requests because these products are no longer manufactured or marketed: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 (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.
