Document ID: FDA-2015-N-0002-0051
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Withdrawal of Approval of New Animal Drug
Applications
Posted Date: 2015-12-09T05:00Z

[Federal Register Volume 80, Number 236 (Wednesday, December 9, 2015)]
[Rules and Regulations]
[Pages 76387-76388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31040]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 558

[Docket No. FDA-2015-N-0002]

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 two new animal drug applications (NADAs) and two abbreviated new 
animal drug applications (ANADAs). This action is being taken at the 
sponsors' requests because these products are no longer manufactured or 
marketed.

DATES: Withdrawal of approval is effective December 21, 2015.

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

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                                                                                                      21 CFR
              File No.                           Sponsor                    Product name              section
----------------------------------------------------------------------------------------------------------------
140-680 \1\.........................  Pharmgate LLC, 1015 Ashes     TYLAN (tylosin phosphate)            558.625
                                       Dr., suite 102, Wilmington,   Premix.
                                       NC 28405.
140-681 \1\.........................  Pharmgate LLC, 1015 Ashes     TYLAN SULFA G (tylosin               558.630
                                       Dr., suite 102, Wilmington,   phosphate and
                                       NC 28405.                     sulfamethazine) Premix.
200-028.............................  Pegasus Laboratories, Inc.,   EVICT 300 (pyrantel pamoate)        520.2043
                                       8809 Ely Rd., Pensacola, FL   Suspension.
                                       32514.
200-383.............................  Bayer HealthCare LLC, Animal  CLINDAROBE (clindamycin)             520.446
                                       Health Division, P.O. Box     Capsules.
                                       390, Shawnee Mission, KS
                                       66201.
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\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 21 CFR 514.116 Notice of withdrawal of approval of 
application, notice is given that approval of NADA 140-680, NADA 140-
681, ANADA 200-028, and ANADA 200-383, and all supplements and 
amendments thereto, is hereby withdrawn, effective December 21, 2015.
    Elsewhere in this issue of the Federal Register, FDA is amending 
the animal drug regulations to reflect the voluntary

[[Page 76388]]

withdrawal of approval of these applications.

    Dated: December 4, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-31040 Filed 12-8-15; 8:45 am]
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