Skip to Content

We invite you to try out our new beta eCFR site at 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!


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.
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


Food and Drug Administration, HHS.


Notification of withdrawal.


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


Withdrawal of approval is effective August 19, 2019.

Start Further Info


Sujaya Dessai, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5761,

End Further Info End Preamble Start Supplemental Information


Boehringer Ingelheim Animal Health USA Inc., 3239 Satellite Blvd., Duluth, GA 30096, has requested that FDA withdraw approval of NADA 141-054 for use of LINCOMIX (lincomycin hydrochloride) and IVOMEC (ivermectin) Type A medicated articles in the manufacture of 2-way, combination drug Type C medicated swine feeds because the product is no longer manufactured or marketed.

Also, Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140, has requested that FDA withdraw approval of NADA 141-337 for use of RECOVYRA (fentanyl) Transdermal Solution for Dogs because the product is no longer manufactured or marketed.

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notice is given that approval of NADAs 141-054 and NADA 141-337, and all supplements and amendments thereto, is hereby withdrawn, effective August 19, 2019.

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: August 1, 2019.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2019-16885 Filed 8-8-19; 8:45 am]