2010-22276. Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin and Betamethasone Ophthalmic Solution

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to codify the conditions of use of an approved new animal drug application (NADA) for gentamicin sulfate and betamethasone acetate ophthalmic solution. This action is being taken to comply with the Federal Food, Drug, and Cosmetic Act and to improve the accuracy of the regulations.

DATES:

This rule is effective September 8, 2010.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8337, email: [e-mail].

SUPPLEMENTARY INFORMATION:

FDA has noticed that the approved conditions of use for GENTOCIN DURAFILM (gentamicin sulfate and betamethasone acetate) Ophthalmic Solution, sponsored by Intervet, Inc., 56 Livingston Ave., Roseland, NJ 07068 under NADA 34-267 are not codified. When this NADA was approved in 1967, codification of approved conditions of use for NADAs was not required. Accordingly, the regulations are amended in 21 CFR part 524 by adding § 524.1044i to reflect the approval. This action is being taken to comply with section 512(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(i)) and to improve the accuracy of the regulations.

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 § 524.1044i to read as follows:

§ 524.1044i

Gentamicin and betamethasone ophthalmic solution.

(a) Specifications. Each milliliter (mL) of solution contains gentamicin sulfate equivalent to 3 milligrams (mg) of gentamicin base and 1 mg betamethasone acetate equivalent to 0.89 mg betamethasone alcohol.

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. Instill one or two drops of solution in the conjunctival sac three or four times a day.

(2) Indications for use. For treatment of external bacterial infections of the eye (conjunctiva and cornea).

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

Dated: September 1, 2010.

Elizabeth Rettie,

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