Document ID: FDA-2019-N-0002-0001
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Withdrawal of Approval of New Animal Drug
Applications
Posted Date: 2019-08-09T04:00Z

[Federal Register Volume 84, Number 154 (Friday, August 9, 2019)]
[Rules and Regulations]
[Page 39187]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16885]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 524 and 558

[Docket No. FDA-2019-N-0002]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of withdrawal.

-----------------------------------------------------------------------

SUMMARY: 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.

DATES: Withdrawal of approval is effective August 19, 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: 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 Sec.  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thereto, is hereby withdrawn, effective August 19, 2019.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.

    Dated: August 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16885 Filed 8-8-19; 8:45 am]
 BILLING CODE 4164-01-P