2011-4545. Withdrawal of Approval of New Animal Drug Applications; Phenylbutazone; Pyrantel; Tylosin; Sulfamethazine

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is withdrawing approval of eight new animal drug applications (NADAs). In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the regulations to remove portions reflecting approval of these NADAs.

DATES:

Withdrawal of approval is effective March 14, 2011.

FOR FURTHER INFORMATION CONTACT:

John Bartkowiak, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9079, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

The sponsors in table 1 have requested that FDA withdraw approval of the three NADAs listed because the products are no longer manufactured or marketed.

Table 1—Voluntary Requests for Withdrawal of Approval (WOA) of Three NADAs

Sponsor	NADA No. product (established name of drug)	21 CFR Section affected (sponsor drug labeler code)
First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 60123	NADA 48-647, Phenylbutazone boluses (phenylbutazone)	520.1720a (058829).
Yoder Feed, Division of Yoder, Inc., Kalona, IA 52247	NADA 96-161, Hy-Con TYLAN Premix (tylosin phosphate)	558.625 (035369).
Triple “F”, Inc., 10104 Douglas Ave., Des Moines, IA 50322	NADA 119-062, Cadco-BN-10 BANMINTH Premix (pyrantel tartrate)	558.485 (011490).

Truow Nutrition, Inc., 1590 Todd Farm Dr., Elgin, IL 60123 (Truow), has informed FDA that it is the sponsor of five feed premix NADAs previously owned by milling companies, which it purchased. NADA 100-352 was owned by NutriBasics Co., last doing business at P.O. Box 1014, Willmar, MN 56201. NADA 107-002 and NADA 123-000 were owned by Seeco, Inc., also last doing business at P.O. Box 1014, Willmar, MN 56201. NADA 133-833 and NADA 135-243 were owned by Southern Micro-Blenders, Inc., last doing business at 3801 North Hawthorne St., Chattanooga, TN 37406. Truow has requested that FDA withdraw approval of the five NADAs in table 2 because they are no longer manufactured or marketed.

Table 2—Voluntary Requests for WOA of Five NADAs by Truow Nutrition, Inc.

Previous sponsor	NADA No., product (established name of drug)	21 CFR section affected (sponsor drug labeler code)
NutriBasics Co., North Highway 71, P.O. Box 1014, Willmar, MN 56201	NADA 100-352, Seeco T-10 Premix (tylosin phosphate)	558.625 (053740).
Seeco, Inc., P.O. Box 1014, North Highway 71, Willmar, MN 56201	NADA 107-002, Seeco TYLAN-Sulfa 10 Premix (tylosin phosphate and sulfamethazine)	Not codified.
Seeco, Inc., P.O. Box 1014, North Highway 71, Willmar, MN 56201	NADA 123-000, Super Swine Wormer B-9 BANMINTH (pyrantel tartrate)	558.485 (011749).
Southern Micro-Blenders, Inc., 3801 North Hawthorne St., Chattanooga, TN 37406	NADA 133-833, TYLAN 10 Premix (tylosin phosphate)	558.625 (049685).
Southern Micro-Blenders, Inc., 3801 North Hawthorne St., Chattanooga, TN 37406	NADA 135-243, Swine Guard-BN BANMINTH Premix (pyrantel tartrate)	558.485 (049685).

Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, and in accordance with § 514.116 Notice of withdrawal of approval of application (21 CFR 514.116), notice is given that approval of NADAs 48-647, 96-161, 100-352, 107-002, 119-062, 123-000, 133-833, and 135-243, and all supplements and amendments thereto, is hereby withdrawn, effective March 14, 2011.

In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect the withdrawal of approval of these NADAs.

Dated: February 18, 2011.

Bernadette Dunham,

Director, Center for Veterinary Medicine.