New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
Federal Register, Volume 83 Issue 62 (Friday, March 30, 2018)
Federal Register Volume 83, Number 62 (Friday, March 30, 2018)
Rules and Regulations
Pages 13637-13638
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2018-06357
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Docket No. FDA-2017-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 three new animal drug applications (NADAs). This action is being taken at the sponsors' request because these products are no longer manufactured or marketed.
DATES: Withdrawal of approval is effective April 9, 2018.
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: During July and August 2017, the following sponsors requested that FDA withdraw approval of the NADAs listed in the following table because the products are no longer manufactured or marketed:
----------------------------------------------------------------------------------------------------------------
File No. Sponsor Product name 21 CFR section
----------------------------------------------------------------------------------------------------------------
047-055............................. Watson Laboratories, Inc., Chorionic Gonadotropin 522.1081
311 Bonnie Circle, Corona, Powder for Injection.
CA 92880.
Page 13638
104-606............................. Watson Laboratories, Inc., Dexamethasone Sodium 522.540
311 Bonnie Circle, Corona, Phosphate Injection.
CA 92880.
139-633............................. Wildlife Laboratories, Inc., WILDNIL (carfentanil 522.300
1230 W. Ash St., suite D, citrate) Injection.
Windsor, CO 80550.
----------------------------------------------------------------------------------------------------------------
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 047-055, 104-606, and 139-633, and all supplements and amendments thereto, is hereby withdrawn, effective April 9, 2018.
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: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
FR Doc. 2018-06357 Filed 3-29-18; 8:45 am
BILLING CODE 4164-01-P