Skip to Content

We invite you to try out our new beta eCFR site at https://ecfr.federalregister.gov. We’ve made big changes to make the eCFR easier to use. Be sure to leave feedback using the 'Help' button on the bottom right of each page!

Rule

New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications

Document Details

Information about this document as published in the Federal Register.

Document Statistics
Document page views are updated periodically throughout the day and are cumulative counts for this document including its time on Public Inspection. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.
Enhanced Content

Relevant information about this document from Regulations.gov provides additional context. This information is not part of the official Federal Register document.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notification of withdrawal.

SUMMARY:

The Food and Drug Administration (FDA) is withdrawing approval of 12 new animal drug applications (NADAs) at the sponsor's request because these products are no longer manufactured or marketed.

DATES:

Withdrawal of approval is effective October 9, 2018.

Start Further Info

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.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137, has requested that FDA withdraw approval of the NADAs listed in the following table because the products are no longer manufactured or marketed:

File No.Product name21 CFR section
011-779PURINA PIGEMIA 100 (colloidal ferric oxide)522.1182
040-205PURINA Horse Wormer Medicated (thiabendazole)520.2380a
042-116PURINA 6 DAY WORM-KILL Feed Premix (coumaphos)558.185
043-215PURINA GRUB-KILL Pour-on Cattle Insecticide (famphur)524.900
046-700STATYL Medicated Premix (nequinate)558.365
091-260PULVEX WORM CAPS (piperazine phosphate monohydrate)520.1804
097-258PURINA BAN-WORM for Pigs (pyrantel tartrate)558.485
102-942PULVEX Multipurpose Worm Caps (dichlorophene, toluene)520.580
113-748PURINA PIGEMIA Oral (iron dextran complex)520.1182
135-941CHECK-R-TON BM (pyrantel tartrate)558.485
136-116PURINA WORM-A-RESTTM Litter Pack Premix (fenbendazole)520.905d
140-869PURINA SAF-T-BLOC BG Medicated Feed Block (poloxalene, 6.6%)520.1840

Therefore, under authority delegated to the Commissioner of Food and Drugs, and in accordance with § 514.116 Notice of withdrawal of approval of application (21 CFR 514.116), notice is given that approval of NADAs 011-779, 040-205, 042-116, 043-215, 046-700, 091-260, 097-258, 102-942, 113-748, 135-941, 136-116, and 140-869, and all supplements and amendments thereto, is hereby withdrawn, effective October 9, 2018.

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.

Start Signature

Dated: September 24, 2018.

Leslie Kux,

Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2018-21147 Filed 9-27-18; 8:45 am]

BILLING CODE 4164-01-P