E7-6828. Ophthalmic and Topical Dosage Form New Animal Drugs; Mupirocin Ointment

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 an abbreviated new animal drug application (ANADA) filed by Altana, Inc. The ANADA provides for veterinary prescription use of mupirocin ointment for the treatment of bacterial skin infections in dogs.

DATES:

This rule is effective April 11, 2007.

FOR FURTHER INFORMATION CONTACT:

John K. Harshman, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Altana, Inc., 60 Baylis Rd., Melville, NY 11747, filed ANADA 200-418 that provides for veterinary prescription use of MURICIN (mupirocin) Ointment 2% for the treatment of bacterial skin infections in dogs. Altana, Inc.'s MURICIN Ointment 2% is approved as a generic copy of Pfizer, Inc.'s BACTODERM Ointment approved under new animal drug application (NADA) 140-839. The ANADA is approved as of March 8, 2007, and the regulations are amended in 21 CFR 524.1465 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.

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 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. Revise § 524.1465 to read as follows:

§ 524.1465

Mupirocin.

(a) Specifications. Each gram of ointment contains 20 milligrams mupirocin.

(b) Sponsors. See Nos. 000069 and 025463 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. Apply twice daily. Treatment should not exceed 30 days.

(2) Indications for use. For the topical treatment of bacterial infections of the skin, including superficial pyoderma, caused by susceptible strains of Staphylococcus aureus and S. intermedius.

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

Dated: March 30, 2007.

Bernadette A. Dunham,

Acting Deputy Director, Center for Veterinary Medicine.