Document ID: FDA-2019-N-5405-0004
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
Posted Date: 2021-02-23T05:00Z

[Federal Register Volume 86, Number 34 (Tuesday, February 23, 2021)]
[Rules and Regulations]
[Pages 10819-10820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03250]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, and 522

[Docket No. FDA-2019-N-5405]

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

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 seven new animal drug applications (NADAs) from multiple holders of 
these applications. The basis for the withdrawals is that the holders 
of these applications have repeatedly failed to file required annual 
reports for the applications.

DATES: Withdrawal of approval is effective February 23, 2021.

FOR FURTHER INFORMATION CONTACT: David Alterman, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-402-5720, david.alterman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The holders of approved applications to 
market new animal drugs are required to submit annual reports to FDA 
concerning each of their approved applications in accordance with Sec.  
514.80 (21 CFR 514.80).
    In the Federal Register of January 8, 2020 (85 FR 919), FDA 
published a notice offering an opportunity for a hearing (NOOH) on a 
proposal to withdraw approval of seven NADAs because the sponsors had 
failed to submit the required annual reports for these applications. 
The holders of these applications did not respond to the NOOH. Failure 
to file a written notice of participation and request for a hearing as 
required by Sec.  514.200(b) (21 CFR 514.200(b)) constitutes an 
election by the applicant not to make use of the opportunity for a 
hearing concerning the proposal to withdraw approval of the 
applications and a waiver of any contentions concerning the legal 
status of the drug products. Therefore, approval of the seven 
applications listed in table 1 is being withdrawn.

             Table 1--NADAs for Which Approval Is Withdrawn
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    Application No.         Trade name  (drug)            Sponsor
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031-971................  CUPRATE (cupric          Walco International,
                          glycinate).              Inc., 15 West Putnam,
                                                   Porterville, CA
                                                   93257.

[[Page 10820]]

 
045-863................  PALOSEIN (orgotein)....  OXIS International,
                                                   Inc., 6040 N. Cutter
                                                   Circle, suite 317,
                                                   Portland, OR 97217-
                                                   3935.
046-922................  SERGEANTS SURE SHOT      ConAgra Pet Products
                          (n[dash]butyl            Co., 3902 Leavenworth
                          chloride) Capsules.      St., Omaha, NE 68105.
046-923................  SERGEANTS (n-butyl       ConAgra Pet Products
                          chloride) Puppy Worm     Co., 3902 Leavenworth
                          Capsules.                St., Omaha, NE 68105.
065-067................  Tetracycline             Premo Pharmaceutical
                          Hydrochloride Tablets.   Laboratories, Inc.,
                                                   111 Leuning St.,
                                                   South Hackensack, NJ
                                                   07606.
140-850................  ELITE (dichlorophene     RSR Laboratories,
                          and toluene) Dog and     Inc., 501 Fifth St.,
                          Cat Wormer.              Bristol, TN 37620.
141-107................  BAPTEN for Injection     Alaco, Inc., 1500
                          ([szlig][dash]aminopro   North Wilmot Rd.,
                          pionitrile fumarate).    suite 290-C, Tucson,
                                                   AZ 85712.
------------------------------------------------------------------------

    The Commissioner of Food and Drugs (the Commissioner), under 
section 512(e)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360b(e)(2)(A)), finds that the holders of the applications 
listed in this document have repeatedly failed to submit reports 
required by Sec.  514.80. In addition, under Sec.  514.200(b), the 
Commissioner finds that the holders of the applications have waived any 
contentions concerning the legal status of the drug products. 
Therefore, under these findings, approval of the applications listed in 
this document, and all amendments and supplements thereto, is hereby 
withdrawn, effective February 23, 2021.
    Elsewhere in this issue of the Federal Register, FDA is amending 
the animal drug regulations to reflect the withdrawal of approval of 
these applications.

    Dated: February 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03250 Filed 2-22-21; 8:45 am]
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