Rules and Regulations. Notification of withdrawal
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/register/2018/09/28/2018-21147A 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 Parts 520, 522, 524, and 558 [Docket No. FDA-2018-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 12 new animal drug applications (NADAs) at the sponsor's request because these products are no longer manufactured or marketed. DATES: Withdrawal of approval is effective October 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: Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137, has requested that FDA withdraw approval of the NADAs listed in the following table because the products are no longer manufactured or marketed: File No. Product name 21 CFR section 011-779 PURINA PIGEMIA 100 (colloidal ferric oxide) 522.1182 040-205 PURINA Horse Wormer Medicated (thiabendazole) 520.2380a 042-116 PURINA 6 DAY WORM-KILL Feed Premix (coumaphos) 558.185 043-215 PURINA GRUB-KILL Pour-on Cattle Insecticide (famphur) 524.900 046-700 STATYL Medicated Premix (nequinate) 558.365 091-260 PULVEX WORM CAPS (piperazine phosphate monohydrate) 520.1804 097-258 PURINA BAN-WORM for Pigs (pyrantel tartrate) 558.485 102-942 PULVEX Multipurpose Worm Caps (dichlorophene, toluene) 520.580 113-748 PURINA PIGEMIA Oral (iron dextran complex) 520.1182 135-941 CHECK-R-TON BM (pyrantel tartrate) 558.485 136-116 PURINA WORM-A-REST TM Litter Pack Premix (fenbendazole) 520.905d 140-869 PURINA SAF-T-BLOC BG Medicated Feed Block (poloxalene, 6.6%) 520.1840 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 011-779, 040-205, 042-116, 043-215, 046-700, 091-260, 097-258, 102-942, 113-748, 135-941, 136-116, and 140-869, and all supplements and amendments thereto, is hereby withdrawn, effective October 9, 2018.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: September 24, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-21147 Filed 9-27-18; 8:45 am]
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