01-140. Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin Sulfate, Mometasone Furoate, Clotrimazole Otic Suspension

AGENCY:

Food and Drug Administration

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 Schering-Plough Animal Health Corp. The NADA provides for veterinary prescription use of gentamicin/mometasone/clotrimazole otic suspension to treat otitis externa in dogs.

DATES:

This rule is effective January 4, 2001.

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.

SUPPLEMENTARY INFORMATION:

Schering-Plough Animal Health Corp., 1095 Morris Ave., Union, NJ 07083, filed NADA 141-177 that provides for veterinary prescription use of MometamaxTM gentamicin sulfate/mometasone furoate/clotrimazole) Otic Suspension for the treatment of otitis externa associated with yeast (Malassezia pachydermatis) and/or bacteria susceptible to gentamicin in dogs. The NADA is approved as of December 5, 2000, and the regulations are amended in 21 CFR 524 by adding §  524.1044h to reflect the approval. The basis of approval is discussed in the freedom of information summary.

In accordance with the freedom of information provisions of 21 CFR part 20 and 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 Dockets Management Branch (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 (the act) (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 3 years of marketing exclusivity beginning December 5, 2000, because the application contains substantial evidence of effectiveness of the drug involved, or any studies of animal safety, required for approval of the application and conducted or sponsored by the applicant.

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—OPTHALMIC 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. Section 524.1044h is added to read as follows:

§ 524.1044h

Gentamicin sulfate, mometasone furoate, clotrimazole otic suspension.

(a) Specifications. Each gram contains gentamicin sulfate, United States Pharmacopeia (USP) equivalent to 3-milligram (mg) gentamicin base, mometasone furoate monohydrate equivalent to 1-mg mometasone, and 10 mg clotrimazole, USP.

(b) Sponsor. See No. 000061 in § 510.6(c) of this chapter.

(c) Conditions of use— Dogs—(1) Amount. For dogs weighing less than 30 pounds (lb), instill 4 drops from the 5- and 30-gram (g) bottle into the ear canal (2 drops from the 215-g bottle) or, for dogs weighing 30 lb or more, instill 8 drops from the 5- and 30-g bottle into the ear canal (4 drops from the 215-g bottle), twice daily for 7 days.

(2) Indications for use. For the treatment of otitis externa associated with yeast (Malassezia pachydermatis) and/or bacteria susceptible to gentamicin in dogs.

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

Dated: December 26, 2000.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.