E6-8309. Implantation or Injectable Dosage Form New Animal Drugs; Trimethoprim and Sulfadiazine

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The supplemental NADA provides for revised food safety labeling for trimethoprim and sulfadiazine injectable suspension, administered to horses as a systemic antibacterial.

DATES:

This rule is effective May 31, 2006.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Schering-Plough Animal Health Corp., 556 Morris Ave., Summit, NJ 07901, filed a supplement to NADA 106-965 for use of TRIBRISSEN (trimethoprim and sulfadiazine) 48% Injection administered to horses as a systemic antibacterial. The supplement provides for revised food safety labeling. The supplemental NADA is approved as of April 26, 2006, and the regulations are amended in § 522.2610 (21 CFR 522.2610) to reflect the approval and a current format. The basis of approval is discussed in the freedom of information summary.

In addition, FDA has found that a 1997 change of sponsorship for NADA 106-965 (62 FR 61625, November 19, 1997) is not reflected in the Code of Federal Regulations. Accordingly, § 522.2610 is being revised to reflect the correct sponsor drug labeler code. This action is being taken to improve the accuracy of the regulations.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 522

• Animal drugs

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is amended as follows:

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 522 continues to read as follows:

Authority: 21 U.S.C. 360b.

2. Revise § 522.2610 to read as follows:

§ 522.2610

Trimethoprim and sulfadiazine.

(a) Specifications. Each milliliter (mL) contains:

(1) 40 milligrams (mg) trimethoprim suspended in a solution containing 200 mg sulfadiazine; or

(2) 80 mg trimethoprim suspended in a solution containing 400 mg sulfadiazine (as the sodium salt).

(b) Sponsors. See Nos. 000061 and 000856 in § 510.600(c) of this chapter.

(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d) Conditions of use—(1) Dogs—(i) Amount. 1 mL of the product described in paragraph (a)(1) of this section (40 mg trimethoprim and 200 mg sulfadiazine) per 20 pounds (9 kilograms) of body weight per day by subcutaneous injection.

(ii) Indications for use. For the treatment of acute urinary tract infections, acute bacterial complications of distemper, acute respiratory tract infections, acute alimentary tract infections, and acute septicemia due to Streptococcus zooepidemicus.

(2) Horses—(i) Amount. 2 mL of the product described in paragraph (a)(2) of this section (160 mg trimethoprim and 800 mg sulfadiazine) per 100 pounds (45 kilograms) of body weight per day by intravenous injection as single, daily dose for 5 to 7 days. The daily dose may also be halved and given morning and evening.

(ii) Indications for use. For use where systemic antibacterial action against sensitive organisms is required during treatment of acute strangles, respiratory tract infections, acute urogenital infections, and wound infections and abscesses.

(iii) Limitations. Not for use in horses intended for human consumption.

Dated: May 18, 2006.

Steven D. Vaughn,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.