Document ID: FDA-2018-N-0002-0004
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Withdrawal of Approval of New Animal Drug
Application
Posted Date: 2019-03-13T04:00Z

[Federal Register Volume 84, Number 49 (Wednesday, March 13, 2019)]
[Rules and Regulations]
[Pages 8982-8983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04222]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2018-N-0002]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of a new animal drug application (NADA) and an abbreviated new animal 
drug application (ANADA) at the sponsors' request because these 
products are no longer manufactured or marketed.

DATES: Withdrawal of approval is effective March 25, 2019.

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: Elanco US Inc., 2500 Innovation Way, 
Greenfield, IN 46140, has requested that FDA withdraw approval of NADA 
140-939 for use of RUMENSIN (monensin) and TYLAN (tylosin phosphate) 
Type A medicated articles in the manufacture of combination drug Type C 
medicated cattle feeds because the product is no longer manufactured or 
marketed.

[[Page 8983]]

    Also, Sergeant's Pet Care Products, Inc., 10077 S 134th St., Omaha, 
NE 68138 has requested that FDA withdraw approval of ANADA 200-600 for 
WORMX (pyrantel pamoate) Flavored Tablets because the product is no 
longer manufactured or marketed.
    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 NADA 
140-939 and ANADA 200-600, and all supplements and amendments thereto, 
is hereby withdrawn, effective March 25, 2019.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.

    Dated: March 4, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04222 Filed 3-12-19; 8:45 am]
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