Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin Sulfate Ophthalmic 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 gentamicin sulfate ophthalmic ointment on dogs and cats for topical treatment of conjunctivitis caused by susceptible bacteria.

DATES:

This rule is effective August 5, 2004.

FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: lonnie.luther@fda.gov.

SUPPLEMENTARY INFORMATION:

Altana Inc., 60 Baylis Rd., Melville, NY 11747, filed ANADA 200-273 for veterinary prescription use of VETRO-GEN (gentamicin sulfate) Veterinary Ophthalmic Ointment on dogs and cats for topical treatment of conjunctivitis caused by susceptible bacteria. Altana Inc.'s VETRO-GEN Veterinary Ophthalmic Ointment is approved as a generic copy of Schering-Plough Animal Health's GENTOCIN Ophthalmic Ointment, approved under NADA 98-989. The ANADA is approved as of June 8, 2004, and 21 CFR 524.1044c is amended to reflect the approval and a current format. 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 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. Section 524.1044c is revised to read as follows:

(a) Specifications. Each gram of ointment contains gentamicin sulfate equivalent to 3 milligrams of gentamicin.

(b) Sponsors. See Nos. 000061 and 025463 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs and cats—(1) Amount. Apply approximately a 1/2-inch strip to the affected eye 2 to 4 times a day.

(2) Indications for use. For treatment of conjunctivitis caused by susceptible bacteria.

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