[Federal Register Volume 59, Number 23 (Thursday, February 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-2400]


[[Page Unknown]]

[Federal Register: February 3, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524

 

Ophthalmic and Topical Dosage Form New Animal Drugs; Neomycin, 
Penicillin, Polymyxin, Hydrocortisone Topical Suspension

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect codification of a previously approved new 
animal drug application (NADA) held by Upjohn Co. The NADA provides for 
the safe use of Forte-Topical Suspension (neomycin, 
penicillin, polymyxin, hydrocortisone suspension) as a topical 
antibacterial and anti-inflammatory agent in dogs.

EFFECTIVE DATE: February 3, 1994.

FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1623.

SUPPLEMENTARY INFORMATION: Upjohn Co., Kalamazoo, MI 49001, is sponsor 
of NADA 65-119 which provides for the safe use of Forte-
Topical Suspension. Each milliliter contains 25 milligrams 
(mg) of neomycin sulfate, 10,000 international units (IU's) of 
penicillin G procaine, 5,000 IU's of polymyxin B sulfate, 2 mg of 
hydrocortisone acetate, and 1.25 mg of hydrocortisone sodium succinate 
for the topical treatment of dogs for summer eczema, atopic dermatitis, 
interdigital eczema, and otitis externa caused by bacteria susceptible 
to neomycin, penicillin, and polymyxin B. The product was originally 
approved on September 15, 1959. Accordingly, the regulations in 21 CFR 
524.1484h are amended to reflect approval of the NADA.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(i) for NADA's approved prior to July 1, 
1975, a summary of safety and effectiveness data and information 
submitted to support approval of this application is not required.
    FDA has determined under 21 CFR 25.24(d)(1)(i) 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.

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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

    2. New Sec. 524.1484h is added to read as follows:

Sec. 524.1484h  Neomycin, penicillin, polymyxin, hydrocortisone 
suspension.

    (a) Specifications. Each milliliter of suspension contains 25 
milligrams of neomycin sulfate equivalent to 17.5 milligrams of 
neomycin, 10,000 international units of penicillin G procaine, 5,000 
international units of polymyxin B sulfate, 2 milligrams of 
hydrocortisone acetate, and 1.25 milligrams of hydrocortisone sodium 
succinate.
    (b) Sponsor. See 000009 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. The labeling shall state: This 
medication contains penicillin. Allergic reactions in humans are known 
to occur from topical exposure to penicillin.
    (d) Conditions of use--dogs--(1) Amount. Rub a small amount into 
the involved area 1 to 3 times a day. After definite improvement, it 
may be applied once a day or every other day.
    (2) Indications for use. Treatment of summer eczema, atopic 
dermatitis, interdigital eczema, and otitis externa caused by bacteria 
susceptible to neomycin, penicillin, and polymyxin B.
    (3) Limitations. For use in dogs only. Shake drug thoroughly and 
clean lesion before using. If redness, irritation, or swelling persists 
or increases, discontinue use and reevaluate diagnosis. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

    Dated: January 27, 1994.
 Robert C. Livingston,
 Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 94-2400 Filed 2-2-94; 8:45 am]
BILLING CODE 4160-01-F