New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
Federal Register, Volume 80 Issue 236 (Wednesday, December 9, 2015)
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
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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
BILLING CODE 4164-01-P
