E7-14945. Ophthalmic and Topical Dosage Form New Animal Drugs; Emodepside and Praziquantel

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 new animal drug application (NADA) filed by Bayer HealthCare LLC. The NADA provides for veterinary prescription use of an emodepside and praziquantel topical solution on cats for the treatment and control of infections by several internal parasites.

DATES:

This rule is effective August 2, 2007.

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:

Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201, filed NADA 141-275 that provides for veterinary prescription use of PROFENDER (emodepside and praziquantel) Topical Solution for the treatment and control of infections by several internal parasites of cats. The NADA is approved as of June 29, 2007, and the regulations are amended in 21 CFR part 524 by adding § 524.775 to reflect the approval.

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.

Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 3 years of marketing exclusivity beginning on the date of the approval.

The agency has determined under 21 CFR 25.33(d)(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 524

• 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 524 is amended as follows:

PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 524 continues to read as follows:

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

2. Add § 524.775 to read as follows:

§ 524.775

Emodepside and praziquantel.

(a) Specifications. Each milliliter of solution contains 21.4 milligrams (mg) emodepside and 85.7 mg praziquantel.

(b) Sponsor. See No. 000859 in § 510.600(c) of this chapter.

(c) Conditions of use in cats—(1) Amount. The recommended minimum dose is 1.36 mg/pound (lb) (3 mg/kilogram (kg)) emodepside and 5.45 mg/lb (12 mg/kg) praziquantel applied as a single topical dose.

(2) Indications for use. For the treatment and control of hookworm infections caused by Ancylostoma tubaeforme (adults, immature adults, and fourth stage larvae), roundworm infections caused by Toxocara cati (adults and fourth stage larvae), and tapeworm infections caused by Dipylidium caninum (adults) and Taenia taeniaeformis (adults).

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dated: July 17, 2007.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.