[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
