81 FR 36790 - New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 110 (June 8, 2016)

The Food and Drug Administration (FDA) is withdrawing approval of five new animal drug applications (NADAs) and an abbreviated new animal drug application (ANADA). This action is being taken at the sponsors' request because these products are no longer manufactured or marketed.

[Federal Register Volume 81, Number 110 (Wednesday, June 8, 2016)]
[Rules and Regulations]
[Pages 36790-36791]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-13518]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 558

[Docket No. FDA-2016-N-0002]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of withdrawal.

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

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

DATES: Withdrawal of approval is effective June 20, 2016.

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, [email protected].

SUPPLEMENTARY INFORMATION: The sponsors of the following applications 
have requested that FDA withdraw approval of the NADAs and ANADA listed 
in the following table because the products are no longer manufactured 
or marketed:

----------------------------------------------------------------------------------------------------------------
           File No.                       Sponsor                    Product name              21 CFR section
----------------------------------------------------------------------------------------------------------------
007-076 \1\..................  Cross Vetpharm Group Ltd.,    SULFA-NOX Liquid              520.2325a
                                Broomhill Rd., Tallaght,      (sulfaquinoxaline) 3.44%
                                Dublin 24, Ireland.           Solution.
008-244 \1\..................  Cross Vetpharm Group Ltd.,    SULFA-NOX Concentrate         520.2325a
                                Broomhill Rd., Tallaght,      (sulfaquinoxaline) 12.85%
                                Dublin 24, Ireland.           Solution.

[[Page 36791]]

 
041-955 \1\..................  Cross Vetpharm Group Ltd.,    Erythromycin Medicated        558.248
                                Broomhill Rd., Tallaght,      Premix.
                                Dublin 24, Ireland.
049-729 \1\..................  Cross Vetpharm Group Ltd.,    PURINA Sulfa                  522.2260a
                                Broomhill Rd., Tallaght,      (sulfamethazine) 12.5%
                                Dublin 24, Ireland.           Solution.
100-128 \1\..................  Cross Vetpharm Group Ltd.,    Supersweet Medipak TYLAN 10.  558.625
                                Broomhill Rd., Tallaght,
                                Dublin 24, Ireland.
200-307 \1\..................  Vetoquinol N.-A., Inc., 2000  Penicillin G Potassium, USP,  520.1696b
                                chemin Georges, Lavaltrie     Soluble Powder.
                                (PQ), Canada J5T 3S5.
----------------------------------------------------------------------------------------------------------------
\1\These NADAs were identified as being affected by guidance for industry #213, ``New Animal Drugs and New
  Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing
  Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209,''
  December 2013.

    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 NADAs 
007-076, 008-244, 041-955, 049-729, 100-128, and ANADA 200-307, and all 
supplements and amendments thereto, is hereby withdrawn, effective June 
20, 2016.
    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: May 31, 2016.
Tracey Forfa,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2016-13518 Filed 6-7-16; 8:45 am]
BILLING CODE 4164-01-P