Rules and Regulations. Notification of withdrawal
292 words·~1 min read·
/register/2018/03/30/2018-06357A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4164-01-P 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, *sujaya.dessai@fda.hhs.gov* . 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., 311 Bonnie Circle, Corona, CA 92880 Chorionic Gonadotropin Powder for Injection 522.1081 104-606 Watson Laboratories, Inc., 311 Bonnie Circle, Corona, CA 92880 Dexamethasone Sodium Phosphate Injection 522.540 139-633 Wildlife Laboratories, Inc., 1230 W. Ash St., suite D, Windsor, CO 80550 WILDNIL (carfentanil citrate) Injection 522.300 Therefore, under authority delegated to the Commissioner of Food and Drugs, and in accordance with § 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is given that approval of NADAs 047-055, 104-606, and 139-633, and all supplements and amendments thereto, is hereby withdrawn, effective April 9, 2018.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]
Connectionstraces to 1
Traces to 1 document
2 references not yet in our index
- 21 CFR 522
- 21 CFR 047
Citation graph
cites case law
Cites 3Cited by 0 across 0 sources