2010-22809. Withdrawal of Approval of New Animal Drug Applications; Chloramphenicol, Lincomycin, Pyrantel Tartrate, and Tylosin Phosphate and Sulfamethazine

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is withdrawing approval of four 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 September 24, 2010.

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, email: [e-mail].

SUPPLEMENTARY INFORMATION:

John J. Ferrante, 11 Fairway Lane, Trumbull, CT 06611; International Nutrition, Inc., 7706 “I” Plaza, Omaha, NE 68127; and Feed Service Co., Inc., 303 Lundin Blvd., P.O. Box 698, Mankato, MN 56001 have requested that FDA withdraw approval of the four NADAs listed in table 1 because they are no longer manufactured or marketed:

Table 1.

Sponsor	NADA Number Product (Established Name of Drug)	21 CFR Cite (Sponsor's Drug Labeler Code)
John J. Ferrante, 11 Fairway Lane, Trumbull, CT 06611	NADA 65-137 AMPHICOL-V Capsules (chloramphenicol)	§ 520.390b (058034)
International Nutrition, Inc., 7706 “I” Plaza, Omaha, NE 68127	NADA 121-337 INI Swine Ban-Wormer B-9.6 BA. (pyrantel tartrate)	§ 558.485 (043733)
International Nutrition, Inc., 7706 “I” Plaza, Omaha, NE 68127	NADA 132-923 LINCO 8/LINCO 20 (lincomycin)	§ 558.325 (043733)
Feed Service Co., Inc., 303 Lundin Blvd., P.O. Box 698, Mankato, MN 56001	NADA 138-342 TYLAN 5 Sulfa-G Premix (tylosin and sulfamethazine)	§ 558.630 (030841)

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that approval of NADAs 65-137, 121-337, 132-923, and 138-342, and all supplements and amendments thereto, is hereby withdrawn, effective September 24, 2010.

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: September 1, 2010.

Bernadette Dunham,

Director, Center for Veterinary Medicine.