2018-21147. 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, [e-mail].

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-RESTTM 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097-258, 102-942, 113-748, 135-941, 136-116, and 140-869, and all supplements and amendments thereto, is hereby withdrawn, effective October 9, 2018.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.